Devices and methods for treating vascular occlusion

ABSTRACT

Systems and methods for removal of thrombus from a blood vessel in a body of a patient are disclosed herein. The method can include: providing a thrombus extraction device including a proximal self-expanding member formed of a fenestrated structure, a substantially cylindrical portion formed of a net-like filament mesh structure having a proximal end coupled to a distal end of the fenestrated structure; advancing a catheter constraining the thrombus extraction device through a vascular thrombus, deploying the thrombus extraction device by stacking a portion of the net-like filament mesh structure outside of the catheter by distally advancing the self-expanding member until the self-expanding member is beyond a distal end of the catheter; retracting the self-expanding member to unstack the portion of the net-like filament mesh structure and to capture the portion of the thrombus; and withdrawing the thrombus extraction device from the body.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/444,705, filed on Jan. 10, 2017, and entitled “INVERTED ORSELF-FEEDING DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION”, theentirety of which is hereby incorporated by reference herein.

This application is related to U.S. Provisional Application No.62/245,935, filed on Oct. 23, 2015, and entitled “INTRAVASCULARTREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS ANDMETHODS”; U.S. patent application Ser. No. 15/268,296, filed on Sep. 16,2016, and entitled “INTRAVASCULAR TREATMENT OF VASCULAR OCCLUSION ANDASSOCIATED DEVICES, SYSTEMS AND METHODS”; U.S. patent application Ser.No. 15/268,406, filed on Sep. 16, 2016, and entitled “INTRAVASCULARTREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS ANDMETHODS”; and International Patent Application No. PCT/US2016/058536,filed on Oct. 24, 2016, and entitled “INTRAVASCULAR TREATMENT OFVASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS AND METHODS”, theentirety of each of which is hereby incorporated by reference herein.

BACKGROUND OF THE INVENTION

Thrombosis is a term for a blood clot occurring inside a blood vessel,and a venous thrombus is a blood clot (thrombus) that forms within avein. A common type of venous thrombosis is a deep vein thrombosis(DVT). DVT is the formation of a blood clot (thrombus) within a deepvein, predominantly in the legs. Nonspecific signs may include pain,swelling, redness, warmness, and engorged superficial veins.

If the thrombus breaks off (embolizes) and flows towards the lungs, itcan become a life-threatening pulmonary embolism (PE), a blood clot inthe lungs. In addition to the loss of life that can arise from PE, DVTcan cause significant health issues such as post thrombotic syndrome,which can cause chronic swelling, pressure, pain, and ulcers due tovalve and vessel damage. Further, DVT can result in significanthealth-care costs either directly or indirectly through the treatment ofrelated complications and inability of patients to work.

Three processes are believed to result in venous thrombosis. These are adecreased blood flow rate (venous stasis), increased tendency to clot(hypercoagulability), and changes to the blood vessel wall. DVTformation typically begins inside the valves of the calf veins, wherethe blood is relatively oxygen deprived, which activates certainbiochemical pathways. Several medical conditions increase the risk forDVT, including diabetes, cancer, trauma, and antiphospholipid syndrome.Other risk factors include older age, surgery, immobilization (as withbed rest, orthopedic casts, and sitting on long flights), combined oralcontraceptives, pregnancy, the postnatal period, and genetic factors.The rate of DVT increases dramatically from childhood to old age and inadulthood, about 1 in 1,000 adults develops it annually.

While current devices and methods of prevention and/or treatment of DVTexist, there are a number of shortcomings that have yet to be resolved,such as high incidence of DVT re-occurrence, use of devices not designedto remove large clot volumes, and/or complicated treatments involvingmultiple treatment devices and/or pharmaceuticals. Accordingly, newdevices, systems, and methods of treating thrombus, and particularly DVTare desired.

BRIEF SUMMARY OF THE INVENTION

Aspects of the present disclosure relate to systems and methods forthrombus extraction, and particularly for thrombus extraction from aperipheral vasculature. The thrombus extraction devices of the presentinvention are designed to remove large clot volumes, including matureand organized clots, with reduced needs for pharmaceuticals, such asthrombolytics. This reduces risk of bleeding, post-treatment recoverytime, and reduces health care procedure costs. The thrombus extractiondevice may comprise a self-expanding coring portion connected to abraided net so as to effectively core and separate large volumes ofthrombus from large vessels in, for example, the venous system orarterial system while capturing the separated thrombus in the braidednet.

One aspect of the present disclosure relates to method for removal ofthrombus from a blood vessel in a body of a patient. The methodincludes: providing a thrombus extraction device. The thrombusextraction device can include: a proximal self-expanding member formedof a fenestrated structure, and a substantially cylindrical portionformed of a net-like filament mesh structure having a proximal endcoupled to a distal end of the fenestrated structure. The methodincludes: advancing a catheter constraining the thrombus extractiondevice through a vascular thrombus, deploying the thrombus extractiondevice by stacking a portion of the net-like filament mesh structureoutside of the catheter by distally advancing the self-expanding memberuntil the self-expanding member is beyond a distal end of the catheter;retracting the self-expanding member relative to the distal end of thenet-like filament mesh structure to unstack the portion of the net-likefilament mesh structure and to separate a portion of the thrombus fromthe vessel wall and to capture the portion of the thrombus within thenet-like filament mesh structure; and withdrawing the thrombusextraction device from the body to remove thrombus from the patient.

In some embodiments, advancing the catheter through the vascularthrombus includes inserting the catheter into the blood vessel until aradiopaque distal tip of the catheter is past the thrombus portion. Insome embodiments, stacking a portion of the net-like filament meshstructure includes: fixing a position of the distal end of the net-likefilament mesh structure; and distally advancing the self-expandingmember relative to the distal end of the net-like filament meshstructure.

In some embodiments, the position of the distal end of the net-likefilament mesh structure is fixed proximal relative to one or severalvalves in the body of the patient. In some embodiments, the position ofthe distal end of the net-like filament mesh structure is fixed in theinferior vena cava, at one or several valves, and/or distal to one orseveral valves. In some embodiments, the valve is located in the bloodvessel containing the thrombus. In some embodiments, the valve islocated in a second blood vessel, wherein the second blood vessel isconnected to the blood vessel containing the thrombus.

In some embodiments, stacking a portion of the net-like filament meshstructure includes changing the braid angle of portion of the net-likefilament mesh structure. In some embodiments, the braid angle of theportion of the net-like filament mesh structure is greater than 45° whenstacked. In some embodiments, a diameter of the portion of the net-likefilament mesh structure is greater than a diameter of the fenestratedstructure. In some embodiments, the catheter is inserted into the bloodvessel through a popliteal access site and the catheter is distallyadvanced from the popliteal access site. In some embodiments, thenet-like filament mesh structure is interwoven on the fenestratedstructure.

In some embodiments the method includes moving the fenestrated structureto full expansion. In some embodiments, moving the fenestrated structureto full expansion includes retracting a stop shaft relative to thefenestrated structure. In some embodiments, the stop shaft is retractedrelative to the fenestrated structure via movement of a plunger from afirst position to a second position. In some embodiments, the stop shaftis retracted relative to the fenestrated structure via movement of ashuttle from a first position to a second position. In some embodiments,the shuttle is moved from a first position to a second position via aforce applied to the shuttle by a spring. In some embodiments, the stopshaft applies a constant pressure on the stop ring. In some embodiments,the stop shaft is replaced by a tether, or filament, to engage thefenestrated structure. In some embodiments, the stop shaft can comprisea filament such as a metal or polymeric filament, a monofilament, and/ora braided or woven strand. This tether or filament can be attachedproximally to the catheter hub or handle, and can apply constant tensionwhen the fenestrated structure is deployed.

In some embodiments, advancing the catheter through the vascularthrombus includes inserting the catheter into the blood vessel through afunnel catheter including: an elongate sheath; and a self-expandingfunnel coupled to a distal end of the elongate sheath. In someembodiments, withdrawing the thrombus extraction device from the body toremove thrombus from the patient includes retracting the thrombusextraction device until at least a portion of the self-expanding memberis contained within the self-expanding funnel. In some embodiments, theat least a portion of the self-expanding member contained within theself-expanding funnel includes an opening of the self-expanding member.In some embodiments, the method includes simultaneously proximallyretracting the thrombus extraction device and the funnel catheter fromthe patient. In some embodiments, the opening of the thrombus extractiondevice is maintained within the self-expanding funnel during thesimultaneous proximal retraction of the thrombus extraction device andthe funnel catheter from the patient.

One aspect of the present disclosure relates to a thrombus extractiondevice for removal of a vascular thrombus from a blood vessel of apatient. The thrombus extraction device includes: a catheter having aproximal end and a distal end, an outer shaft defining a first lumen, acoring element shaft defining a second lumen, a stop shaft, and a tipshaft. In some embodiments, the stop shaft can define a third lumen, andin some embodiments, the tip shaft can define a tip lumen. In someembodiments, the coring element shaft is coaxial the first lumen and thetip shaft is coaxial the second lumen. The thrombus extraction deviceincludes a self-expanding coring element formed of a fenestratedstructure having an opening at a proximal end and configured to core andseparate a portion of the vascular thrombus from the blood vessel. Insome embodiments, the proximal end of the fenestrated structure iscoupled to a distal end of the coring element shaft. The thrombusextraction device can include an expandable cylindrical portion formedof a filament mesh structure that can capture the vascular thrombusportion. In some embodiments, a proximal end of the mesh structure iscoupled to a distal end of the fenestrated structure. In someembodiments, the stop shaft is displaceable independent of the tip shaftwith respect to the coring element shaft and the proximal end theself-expanding coring element to move the self-expanding coring elementto an expanded state.

In some embodiments, the filament mesh structure is interwoven on thefenestrated structure. In some embodiments the thrombus extractiondevice further includes an expansion mechanism that can maintain adesired radial force on a vessel wall with the self-expanding coringelement. In some embodiments, the expansion mechanism can hold thefenestrated structure in full expansion. In some embodiments, theexpansion mechanism includes a ring feature of the fenestrated structureand a stop feature that can engage with the ring feature when thefenestrated structure is in full expansion. In some embodiments, thestop feature can engage with the ring feature when the fenestratedstructure is in full expansion and throughout the full travel and/ordiameter range of the fenestrated structure. In some embodiments, thestop feature can be a tab on a stop shaft. In some embodiments, the tabcan engage with the ring feature, and the stop shaft is coaxial with thefirst lumen.

In some embodiments, the thrombus extraction device can include a handleincluding a plunger that can control a relative position of the stopshaft with respect to the coring element shaft and that can selectivelysecure the relative position of the stop shaft with respect to thecoring element shaft. In some embodiments, the thrombus extractiondevice further includes a handle having a spring connected to the stopshaft via a displaceable shuttle. In some embodiments, the shuttle isdisplaceable between a first position in which self-expanding coringelement is collapsed and a second position in which self-expandingcoring element is expanded. In some embodiments, the spring includes atleast one of: a constant force spring; a tension spring; or acompression spring. In some embodiments, the spring can include anymeans for applying force to the stop including, for example, anelastomer, a pressure chamber, a hydraulic or pneumatic piston, or atorsion spring.

One aspect of the present disclosure relates to a funnel catheter foraccessing and removing thrombus within a blood vessel of a patient. Thefunnel catheter includes: an elongate sheath having a proximal end, adistal end, and a lumen extending therebetween; a self-expanding funnelcoupled to the distal end of the elongate sheath; and a dilator assemblythat can be received within the lumen of the capture sheath. The dilatorassembly includes: an obturator having an elongate shaft having proximalend, a distal end, and a capture sheath proximate to the distal end,which capture sheath can retain the self-expanding funnel in aconstrained configuration. In some embodiments, the dilator assembly caninclude a moveable shaft coaxially extending along a portion of theelongate shaft of the obturator between the proximal end of theobturator and the capture sheath. In some embodiments the moveable shaftincludes a mating feature at a distal end of the moveable shaft, whichmating feature can mate with the capture sheath.

In some embodiments, the funnel catheter includes a sealed hub locatedat the proximal end of the elongate sheath. In some embodiments, thesealed hub can include an aspiration port. In some embodiments, theself-expanding funnel has a diameter equal to or less than a diameter ofthe capture sheath when the self-expanding funnel is in the constrainedconfiguration. In some embodiments, the moveable shaft has a diameterequal to the diameter of the capture sheath. In some embodiments, themoveable shaft is moveable between a loading position and a retractingposition. In some embodiments, the moveable shaft includes a connectingfeature that can connect the moveable shaft to the proximal end of theproximal end of the elongate shaft when the moveable shaft is in theloading position. In some embodiments, the mating feature of themoveable shaft can mate with the capture sheath when the moveable shaftis in the retracting position.

One aspect of the present disclosure relates to a method of accessingand removing thrombus from a venous vessel of a patient. The methodincludes percutaneously accessing a venous vessel of a patient throughan access site with a funnel catheter. In some embodiments, the funnelcatheter includes an elongate sheath defining a lumen, a self-expandingfunnel coupled to a distal end of the elongate sheath, and a dilatorassembly including: an elongate obturator extending through the lumenand retaining the self-expanding funnel in a constrained configurationwithin a capture sheath of the obturator; and a moveable shaft coaxiallyextending along a portion of the elongate obturator. In someembodiments, the access site can be a popliteal access site, a femoralaccess site, a mid-femoral access site, a tibial access site, acontralateral access site, or an internal jugular access site. Themethod includes: advancing a distal end of the funnel catheter to aposition proximal of a thrombus; deploying the self-expanding funnelfrom the constrained configuration within the capture sheath to anexpanded configuration free of the capture sheath; capturing thrombus inthe self-expanding funnel; and aspirating the captured material throughthe lumen of the elongate sheath.

In some embodiments, deploying the self-expanding funnel includes:distally advancing the dilator assembly relative to the elongate sheathto unsheathe the self-expanding funnel from the constrainedconfiguration to the expanded configuration; displacing the moveableshaft from a loading position to a retracting position; and removing thedilator assembly from the funnel catheter by proximally retracting thedilator assembly through the deployed self-expanding funnel and throughthe lumen of the elongate sheath. In some embodiments, deploying theself-expanding funnel can include: proximally retracting the elongatesheath over the dilator assembly to unsheathe the self-expanding funnelfrom the constrained configuration to the expanded configuration;displacing the moveable shaft from a loading position to a retractingposition; and removing the dilator assembly from the funnel catheter byproximally retracting the dilator assembly through the deployedself-expanding funnel and through the lumen of the elongate sheath. Insome embodiments, a mating feature of the moveable shaft mates with thecapture sheath when the moveable shaft is in the retracting position

In some embodiments, the method includes inserting a catheterconstraining a thrombus extraction device through the lumen of theelongate sheath so that a distal tip of the catheter is distally pastthe vascular thrombus portion, deploying the thrombus extraction devicefrom the catheter, and proximally retracting the thrombus extractiondevice relative to the funnel catheter until an opening of the thrombusextraction device is within the self-expanding funnel. In someembodiments, the method includes percutaneously accessing a venousvessel of a patient with an introducer sheath through the access site.In some embodiments, percutaneously accessing the venous vessel of thepatient with the funnel catheter through the access site includesinserting the funnel catheter into the venous vessel through theintroducer sheath. In some embodiments, the method includessimultaneously proximally retracting the thrombus extraction device andthe funnel catheter from the patient via the introducer sheath. In someembodiments, the opening of the thrombus extraction device is maintainedwithin the self-expanding funnel during the simultaneous proximalretraction of the thrombus extraction device and the funnel catheterfrom the patient.

One aspect of the present disclosure relates to a method for removal ofthrombus from a blood vessel in a body of a patient. The method includesproviding a thrombus extraction device having a proximal self-expandingmember formed of a unitary fenestrated structure, a substantiallycylindrical portion formed of a net-like filament mesh structure havinga non-everted portion coupled to a distal end of the unitary fenestratedstructure and an everted portion extending proximally through theunitary fenestrated structure, and an inner shaft member coupled to adistal end of the net-like filament mesh structure. The method caninclude: advancing a catheter constraining the thrombus extractiondevice through a vascular thrombus; and deploying the thrombusextraction device by either advancing the unitary fenestrated structurebeyond a distal end of the catheter or retracting the catheter relativeto the unitary fenestrated structure thus exposing the unitaryfenestrated structure and the non-everted portion of the net-likefilament mesh structure distally past a portion of the thrombus andallowing expansion of the unitary fenestrated structure to engage a wallof the blood vessel. The method can include: distally advancing at leasta part of the everted portion of the net-like filament mesh structurethrough the unitary fenestrated structure; retracting the thrombusextraction device to separate a portion of the thrombus from the vesselwall and to capture the portion of the thrombus within the net-likefilament mesh structure; and withdrawing the thrombus extraction devicefrom the body to remove thrombus from the patient.

In some embodiments, advancing the catheter through the vascularthrombus includes inserting the catheter into the blood vessel until aradiopaque distal tip of the catheter is past the thrombus portion. Insome embodiments, distally advancing at least a part of the evertedportion includes: fixing a position of a radiopaque tip of the innershaft; and proximally retracting the unitary fenestrated structure. Insome embodiments, the position of the radiopaque tip is fixed proximalrelative to a valve of the blood vessel. In some embodiments, thecatheter is inserted into the blood vessel through a popliteal accesssite and the catheter is distally advanced from the popliteal accesssite.

In some embodiments, distally advancing at least a part of the evertedportion of the net-like filament mesh structure through the unitaryfenestrated structure increases a size of the non-everted portion of thenet-like filament mesh structure relative to a size on the evertedportion of the net-like filament mesh structure. In some embodiments,the at least a part of the everted portion of the net-like filament meshstructure is distally advanced through the unitary fenestrated structureuntil the portion of the thrombus is wholly contained in the net-likefilament mesh structure.

In some embodiments, the net-like filament mesh structure everts onitself. In some embodiments, the method includes limiting proximalmovement of the inner shaft with respect to the unitary fenestratedstructure to prevent full eversion of the net-like filament mesh. Insome embodiments, the net-like filament mesh structure is integrallyformed on the unitary fenestrated structure. In some embodiments, thenet-like filament mesh structure everts inside of and/or on the unitaryfenestrated structure. In some embodiments, the method includes:retracting an intermediate shaft member relative to the catheter and theunitary fenestrated structure until a stop feature fixed on theintermediate shaft member engages a corresponding feature on thefenestrated structure; and locking the intermediate shaft member withrespect to the unitary fenestrated structure for full expansion of theunitary fenestrated structure. In some embodiments, the method includesunlocking the intermediate shaft member with respect to the unitaryfenestrated structure prior to withdrawing the thrombus extractiondevice from the body. In some embodiments, the thrombus extractiondevice as constrained within the catheter includes the non-evertedportion and the everted portion extending proximally through the unitaryfenestrated structure.

One aspect of the present disclosure relates to a thrombus extractiondevice for removal of a vascular thrombus from a blood vessel of apatient. The thrombus extraction device can include a catheter having aproximal end and a distal end, an outer shaft defining a first lumen, afirst intermediate shaft defining a second lumen, and an inner shaft. Insome embodiments, the first intermediate shaft is coaxial the firstlumen and the inner shaft is coaxial the second lumen. The thrombusextraction device can include a self-expanding coring element formed ofa unitary fenestrated structure having an opening at a proximal end thatcan core and separate a portion of the vascular thrombus from the bloodvessel. In some embodiments, the proximal end of the fenestratedstructure is coupled to a distal end of the first intermediate shaft.The thrombus extraction device can include an expandable cylindricalportion formed of a braided filament mesh structure having an evertedportion. In some embodiments, the braided filament mesh structure cancapture the vascular thrombus portion. In some embodiments, a proximalend of the mesh structure is coupled to a distal end of the fenestratedstructure, and the everted portion of the mesh structure extendsproximally through the opening of the unitary fenestrated structure. Insome embodiments, a length of the everted portion relative to thenon-everted portion of the braided filament mesh structure varies basedon a position of the first intermediate shaft relative to the innershaft of the catheter.

In some embodiments, the net-like filament mesh structure is integrallyformed on the unitary fenestrated structure. In some embodiments, thenet-like filament mesh structure everts on the unitary fenestratedstructure. In some embodiments, the braided filament mesh structureincludes a non-everted portion coupled to the distal end of thefenestrated structure. In some embodiments, the distal end of thebraided mesh is coupled to the inner shaft. In some embodiments, thedistal end of the braided mesh is fixedly coupled to the inner shaft. Insome embodiments, the distal end of the braided mesh is slidably coupledto the inner shaft.

In some embodiments, the thrombus extraction device can include anexpansion mechanism that can maintain a desired radial force on a vesselwall with the unitary fenestrated structure. In some embodiments, theexpansion mechanism can hold the unitary fenestrated structure in fullexpansion. In some embodiments, the expansion mechanism includes a ringfeature of the unitary fenestrated structure and a stop feature that canengage with the ring feature when the unitary fenestrated structure isin full expansion. In some embodiments, the stop feature can be a tab ona second intermediate shaft. In some embodiments, the tab can engagewith the ring feature, and the second intermediate shaft can be coaxialwith the first lumen. In some embodiments, the stop feature can be atension spring dynamically coupled with the ring feature.

In some embodiments, the net-like filament mesh structure everts onitself. In some embodiments, the thrombus extraction device can includean eversion stop that can limit proximal movement of the inner shaftwith respect to the unitary fenestrated structure to prevent fulleversion of the net-like filament mesh structure. In some embodiments,the net-like filament mesh structure can include a plurality offilaments and can have a first pore size at a proximal portion and asecond pore size at a distal portion. In some embodiments, the firstpore size is different from the second pore size. In some embodiments,the at least some of the plurality of filaments are longitudinallyoverlaid in the distal portion. In some embodiments, the self-expandingcoring element and the expandable cylindrical portion are containedwithin the outer shaft of the catheter such that the everted portion ofthe mesh structure extends proximally through the opening of the unitaryfenestrated structure.

One aspect of the present disclosure relates to a method for removal ofthrombus from a blood vessel in a body of a patient. The method includesadvancing a catheter constraining the thrombus extraction device througha vascular thrombus. In some embodiments, the thrombus extraction deviceincludes a proximal self-expanding member formed of a fenestratedstructure, and a substantially cylindrical portion formed of a net-likefilament mesh structure having a proximal end coupled to a distal end ofthe fenestrated structure. The method includes: deploying the thrombusextraction device by distally advancing the self-expanding member withrespect to the catheter until the self-expanding member is beyond adistal end of the catheter; retracting the self-expanding memberrelative to the distal end of the net-like filament mesh structure toincrease a distal length of the net-like filament mesh structure and toseparate a portion of the thrombus from the vessel wall and to capturethe portion of the thrombus within the net-like filament mesh structure;and withdrawing the thrombus extraction device from the body to removethrombus from the patient.

Further areas of applicability of the present disclosure will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples, whileindicating various embodiments, are intended for purposes ofillustration only and are not intended to necessarily limit the scope ofthe disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of a thrombectomy systemfor removal of a thrombus from a blood vessel of a patient.

FIG. 2 is a side view of one embodiment of the thrombus extractioncatheter having a thrombus extraction device is a deployedconfiguration.

FIG. 3 is a side view of one embodiment of the thrombus extractioncatheter having a thrombus extraction device is a deployed configurationat full expansion.

FIG. 4 is a side view of one embodiment of a self-expanding coringelement.

FIG. 5 is a top view of one embodiment of a self-expanding coringelement.

FIG. 6 is a front view of one embodiment of a self-expanding coringelement.

FIG. 7 is a side view of one embodiment of the thrombus extractiondevice in a full expansion configuration.

FIG. 8 is a view of one embodiment of a ball shaped thrombus captured ina thrombus extraction device.

FIG. 9 is a side view of one embodiment of the braided filament meshstructure having multiple pore sizes.

FIG. 10 is a side view of one embodiment of the thrombus extractiondevice including a plurality of circumferential grooves.

FIG. 11 is a schematic illustration of one embodiment of a braidingand/or weaving pattern for forming the cylindrical portion and/or thebraided filament mesh structure onto the self-expanding coring element.

FIG. 12 is a section view of an embodiment of the handle with a plungerin a first position.

FIG. 13 is a section view of an embodiment of the handle with a plungerin a second position.

FIG. 14 is a close-up, section view of a portion of the handle with aplunger in a second position.

FIG. 15 is a side view of one embodiment of an obturator having aconstant dimension of an elongate shaft.

FIG. 16 is a side view of one embodiment of an obturator having avariable dimension of an elongate shaft.

FIG. 17 is a detailed section view of one embodiment of the capturesheath of the obturator.

FIG. 18 is a side view of one embodiment of an introducer sheath in anundeployed configuration.

FIG. 19 is a side view of one embodiment of an introducer sheath in apartially deployed configuration.

FIG. 20 is a side view of one embodiment of an introducer sheath in adeployed configuration.

FIG. 21 is a side view of one embodiment of an introducer sheathcomprising an inflatable balloon.

FIG. 22 is a schematic depiction of one embodiment of accessing theblood vessel via a popliteal access site.

FIGS. 23-A through 23-H are views depicting one embodiment of a processfor fully expanding the thrombus extraction device in a blood vessel.

FIGS. 24-A and 24-B are views depicting alternative steps in the processfor fully expanding the thrombus extraction device in a blood vessel.

FIGS. 25-A through 25-H are views depicting one embodiment of a processfor removal of thrombus with an expanded thrombus extraction device.

FIG. 26 is a schematic depiction of one embodiment of accessing theblood vessel via an internal jugular access site.

FIG. 27 is a schematic depiction of one embodiment of accessing theblood vessel via a popliteal access site with an extension sheath 2300.

FIG. 28 is a schematic depiction of one embodiment of accessing theblood vessel via a popliteal access site and a femoral access site.

FIG. 29 is a side view of an embodiment of the thrombus extractiondevice with an everted portion.

FIG. 30 is a side, section view of an embodiment of the thrombusextraction device with an everted portion and an expansion mechanism.

FIG. 31 is a side, section view of an embodiment of the thrombusextraction device with an everted portion and a coupling.

FIG. 32 is a side view of one embodiment of the thrombus extractiondevice with an everted portion having a first length.

FIG. 33 is a side view of one embodiment of the thrombus extractiondevice with an everted portion having a second length.

FIGS. 34-A to 34-D are views depicting one embodiment of a process foraffecting the relative lengths of the everted portion and thenon-everted portion of a thrombus extraction device in a blood vessel.

FIG. 35 is a schematic illustration of one embodiment of a funnelcatheter.

FIG. 36 is schematic illustration of one embodiment of a dilatorassembly with a moveable sheath in a loading position.

FIG. 37 is schematic illustration of one embodiment of a dilatorassembly with a moveable sheath in a retracting position.

FIGS. 38-A to 38-D are views depicting one embodiment of steps in aprocess for deploying the self-expanding funnel of a funnel catheter.

FIG. 39 is a top view of one embodiment of a stackable thrombusextraction device.

FIG. 40 is a section view of one embodiment of a handle and a shuttle ofthe thrombectomy system.

FIGS. 41-A to 41-F are views depicting one embodiment of steps in aprocess for expanding a stackable thrombus extraction device in a bloodvessel.

FIGS. 42-A and 42-B are views depicting one embodiment of steps in aprocess for retracting stackable thrombus extraction device throughthrombus in a blood vessel.

DETAILED DESCRIPTION OF THE INVENTION

The present disclosure relates to a thrombectomy system for removal of avascular thrombus from a blood vessel of a patient. The thrombectomysystem can remove thrombus from a blood vessel, and particularly from avenous vessel of a patient via the coring of the thrombus and/or theseparating of the thrombus from the walls of the blood vessel that canoccur when the thrombectomy system is retracted through the vascularthrombus. Thrombus that is cored and/or separated from the walls of theblood vessel can be captured within the thrombectomy system and removedfrom the patient.

The thrombectomy system can include a thrombus extraction catheterincluding a Thrombus Extraction Device (“TED”). The TED can include aproximal self-expanding coring element that can be a stent portionand/or that can be formed of a fenestrated structure such as, forexample, a unitary fenestrated structure. In some embodiments, theself-expanding coring element can be a semi-rigid structure that can be,for example, a semi-rigid collapsible structure. The TED can include adistal expandable cylindrical portion formed of a braided filament meshstructure that can, in some embodiments, include an everted portion anda non-everted portion. The braided filament mesh structure can beformed, looped, and/or interwoven on the coring element to thereby forma unitary TED, also referred to herein as an interwoven TED. Thisforming of the braided filament mesh structure directly on the coringelement can eliminate problems, such as: inconsistent materialproperties, decreased flexibility, decreased strength, and/or qualitycontrol issues, arising from connecting the braided filament meshstructure to the coring element via, for example, welding or adhesive.

Thrombectomy systems including a TED having an everted portion and anon-everted portion can allow use of the thrombectomy system in bloodvessels having smaller diameters than would be otherwise possible andcan decrease the potential damage inflicted to valves located in theblood vessel. Specifically, such thrombus extraction devices can limitthe length of the blood vessel used in deploying the TED, andparticularly limit the length of the blood vessel beyond the thrombusused in deploying the thrombus extraction device allowing the TED toextract thrombus more distally located. Thus, the number of valvesthrough which the thrombus extraction device extends can be reduced andpotential valve damage can be prevented. Additionally, due to theeverting nature of the TED, the device can be operated in such a waythat is either in the same direction as the venous blood flow orretrograde the venous blood flow. In some embodiments, operation in thesame direction as venous blood flow can further reduce the potentialdamage caused to the venous valves by the TED.

The expansion of the TED can be controlled by the relative movement ofportions of the thrombus extraction catheter. For example, a proximalend of the TED, and specifically a proximal end of the self-expandingcoring element can be connected to an intermediate shaft that isslidable within an outer shaft of the thrombus extraction catheter. Adistal end of the TED, and specifically a distal end of the expandablecylindrical portion can be either fixedly or slidably connected to aninner shaft that is slidable within the intermediate shaft of thethrombus extraction catheter. As the inner shaft and the intermediateshaft are slidable with respect to the outer shaft, the TED can bewithdrawn into the outer shaft to constrain the TED to an undeployedconfiguration, also referred to herein as a constrained configuration.Similarly, the TED can be deployed from the outer shaft by the relativemovement of the intermediate shaft with respect to the outer shaft. Insome embodiments, after the TED has been deployed from the outer shaft,the inner shaft and the intermediate shaft can be moved with respect toeach other to either expand or contract the expandable cylindricalportion of the TED and to bring the self-expanding coring element tofull expansion. In some embodiments, after the TED has been deployedfrom the outer shaft, the inner shaft and the intermediate shaft can bemoved with respect to each other to change the length of the evertedportion and the non-everted portion.

In some embodiments, self-expanding coring element can be controlledindependent of the expandable cylindrical portion, and/or the expandablecylindrical portion can be controlled independent of the self-expandingcoring element. In some embodiments, for example, the TED can beself-expanding coring element can be relatively distally advancedtowards the expandable cylindrical portion. In such an embodiment, theexpandable cylindrical portion can compress, also referred to herein as“stack” which can, in some embodiments, result in a decreased length ofthe expandable cylindrical portion and, in some embodiments, can resultin an increased diameter of at least a portion of the expandablecylindrical portion. In some embodiments, the ability to control theself-expanding coring element independent of the expandable cylindricalportion, and the ability to stack the expandable cylindrical portion canallow the use of the thrombectomy system, and can specifically allow thecapturing of large and/or lengthy thrombus without having the TED, andspecifically the expandable cylindrical portion far beyond the locationof the thrombus. In some embodiments, this limited extension of theexpandable cylindrical portion beyond the location of the thrombus canease the use of the thrombectomy system by limiting the extension of thethrombectomy system beyond the thrombus. In some embodiments, forexample, this limitation of the extension of the thrombectomy systembeyond the thrombus can mitigate risk of damage to tissues, bloodvessels, and/or organs beyond the thrombus from the thrombectomy system.Specifically, such thrombus extraction devices can limit the length ofthe blood vessel used in deploying the TED, and particularly limit thelength of the blood vessel beyond the thrombus used in deploying thethrombus extraction device. Thus, risk of damage to blood vessels,tissues, and/or organs beyond the thrombus can be minimized via stackingof the TED.

The thrombectomy system can include an introducer sheath that can besized to slidably receive the outer sheath of the thrombus extractioncatheter. In some embodiments, the introducer sheath can include asealed aperture at a proximal end of the introducer sheath and aself-expanding funnel. In some embodiments, the introducer sheath caninclude a sealed aperture at a proximal end and an open distal end, andthe thrombectomy system can include a funnel catheter having aself-expanding funnel. The self-expanding funnel can be located at adistal end of the introducer sheath and can be selectably held in aconstrained position by a capture sheath. In some embodiments, theself-expanding funnel can be slidably contained within the introducersheath and can specifically be slidable with respect to the distal endof the introducer sheath. In some embodiments, the self-expanding funnelcan be distally slid from a constrained configuration within theintroducer sheath to a deployed configuration at which theself-expanding funnel extends from the distal end of the capture sheath.

The self-expanding funnel can be sized to engage with the self-expandingcoring element when the TED is retracted towards the funnel. As the TEDis retracted into the funnel, the funnel compresses the TED, andspecifically the coring element, and guides the TED, and specificallythe coring element into a lumen defined by the introducer sheath. TheTED can be retracted until it is completely contained within theintroducer sheath, and then the TED and the thrombus captured in the TEDcan be removed from the patient via the sealed aperture. Alternatively,in some embodiments, the TED can be retracted until all or a portion ofthe coring element is contained within the funnel attached to the funnelcatheter, and the funnel catheter and the TED can then be simultaneouslyretracted, in some embodiments, through the introducer sheath.

The thrombectomy system can access the blood vessel containing thethrombus via a plurality of access sites. These can include, forexample, an internal jugular (U) access site, a femoral access site, apopliteal access site, or other venous or arterial access sites. Thethrombectomy system can be used to extract thrombus and/or embolus froma variety of venous and/or arterial vessels, which can be peripheralvessels, including any vessel, including, by way of non-limitingexample, a venous vessel, having a diameter of at least 3 millimeters(mm). The thrombectomy system can be inserted through an access pointinto a circulatory system of a patient and can be advanced to a positionproximate to the thrombus. The TED can then be advanced through thethrombus, and, after being expanded distally of the thrombus, the TEDcan be retracted through the thrombus, thereby capturing all or portionsof the thrombus.

With reference now to FIG. 1, one embodiment of a thrombectomy system100, also referred to herein as a thrombus extraction system 100, isshown. The thrombectomy system 100 can be used to access a portion of ablood vessel such as a venous vessel containing thrombus and thethrombectomy system 100 can be used to remove all or portions of thatthrombus from the blood vessel. The thrombectomy system 100 can includean introducer sheath 102 and a thrombus extraction catheter 104.

The introducer sheath 102 comprises an elongate member 106, alsoreferred to herein as an elongate sheath 106, having a proximal end 108and a distal end 110. The elongate member 106 can be elastic and/orflexible. The elongate member 106 can comprise any desired length andany desired diameter. In some embodiments, the elongate sheath 106 canhave an outer diameter of at least 10 French, at least 12 French, atleast 14 French, at least 18 French, at least 20 French, at least 22French, between 14 French and 24 French, between 15 French and 21French, between 16 French and 22 French, and/or any other orintermediate size.

The elongate member 106 can comprise a radiopaque marker that can be,for example, part of the distal end 110 of the elongate member 106. Theelongate member 106 defines a lumen extending between the proximal end108 and the distal end 110. The lumen 1701 (shown in FIG. 17) of theelongate member 106 can be sized to slidably receive the thrombusextraction catheter 104. In some embodiments, the lumen 1701 of theelongate member 106 can have an internal diameter of at least 2 French,at least 10 French, at least 14 French, at least 18 French, at least 20French, at least 22 French, between 11 French and 12 French, between 10French and 22 French, between 14 French and 21 French, between 16 Frenchand 20 French, and/or any other or intermediate size. The lumen 1701 canterminate at a sealed aperture 112, also referred to herein as a sealedhub 112, located at the proximal end 108 of the elongate member 106. Insome embodiments, the sealed aperture 112 can be self-sealing and/or cancomprise a self-sealing seal.

The introducer sheath 102 can further include an aspiration port 114that can be at the proximal end 108 of the elongate member 106 and/orconnected to the proximal end 108 of the elongate member 106 via, forexample, a connecting tube 116. In some embodiments, the aspiration port114 can be a part of, and/or connected to the sealed hub 112. In someembodiments, the aspiration port 114 can be selectively fluidlyconnected to the lumen 1701 via, for example, a valve 118, also referredto herein as an aspiration valve 118, which valve 118 can be a tubingclamp that can be located at a position along the connecting tube 116between the lumen 1701 and the aspiration port 114.

The introducer sheath 102 can further hold an obturator 120, alsoreferred to herein as a dilator 120. The obturator 120 can be configuredto hold a self-expanding funnel that can be attached to the distal end110 of the elongate member 106 in a constrained configuration, and torelease the self-expanding funnel from that constrained configuration.The obturator 120 can comprise a proximal end 122, a distal end 124, andan elongate shaft 126 extending therebetween. In some embodiments, theelongate shaft 126 can have a length that is greater than a length ofthe elongate member 106 of the introducer sheath 102. The obturator 120can further define a lumen extending through the obturator 120, whichlumen can receive a guidewire. In some embodiments, the guidewire cancomprise any desired dimensions and can, in some embodiments, have adiameter of approximately 0.035 inches. The obturator 120 can be sizedand shaped so as to be able to slidably move through the lumen of theelongate member 106.

The thrombectomy system 100 can include the thrombus extraction catheter104. The thrombus extraction catheter 104 can have a proximal end 130and a distal end 132. A handle 134, also referred to herein as adeployment handle 134, can be located at the proximal end 130 of thethrombus extraction catheter 104 and can connect to a catheter portion136, also referred to herein as the catheter 136.

The catheter 136 can include an outer shaft 138, an intermediate shaft140, also referred to herein as a first intermediate shaft 140 or as acoring element shaft 140, a second intermediate shaft, also referred toherein as a stop shaft, a third intermediate shaft, and an inner shaft,also referred to herein as the tip shaft. The outer shaft 138 cancomprise a variety of lengths and sizes. In some embodiments, the outershaft 138 can be sized to slidably fit within the introducer sheath 102.In some embodiments, the outer shaft 138 can have a size of at least 8French, at least 10 French, at least 11 French, at least 12 French, atleast 14 French, at least 16 French, between 8 French and 14 French,between 11 French and 12 French, and/or any other or intermediate size.

Each of the outer shaft 138, the one or several intermediate shafts 140,3000, 3002, and the inner shaft can define a lumen that can be acentral, axial lumen. In some embodiments, the intermediate shaft 140can be sized and/or shaped to slidably fit within the lumen 802 (shownin FIG. 8) of the outer shaft 138 such that the intermediate shaft 140and the outer shaft 138 are coaxial. Similarly, in some embodiments, theinner shaft can be sized and/or shaped to slidably fit within the lumen804 (shown in FIG. 8) of the intermediate shaft 140 such that the innershaft and the intermediate shaft 140 are coaxial. In this configuration,each of the outer shaft 138, the intermediate shaft 140, and the innershaft can be displaced relative to the others of the outer shaft 138,the intermediate shaft 140, and the inner shaft.

In some embodiments, the first intermediate shaft 140 can be sizedand/or shaped to slidably fit within the lumen 802 (shown in FIG. 8) ofthe outer shaft 138 such that the intermediate shaft 140 and the outershaft 138 are coaxial, the second intermediate shaft 3000, also referredto herein as the stop shaft 3000, can be sized and/or shaped to slidablyfit within the first intermediate shaft 140, and/or the thirdintermediate shaft 3002 can sized and/or shaped to slidably fit withinthe second intermediate shaft 3000. Similarly, in some embodiments, theinner shaft can be sized and/or shaped to slidably fit within the secondintermediate shaft 3000 or the third intermediate shaft 3002 such thatthe inner shaft and the intermediate shaft 140 are coaxial. In thisconfiguration, each of the outer shaft 138, the intermediate shafts 140,3000, 3002, and the inner shaft can be displaced relative to the othersof the outer shaft 138, the intermediate shafts 140, 3000, 3002, and theinner shaft.

In some embodiments, each of the outer shaft 138, the intermediateshafts 140, 3000, 3002, and the inner shaft can have the same length,and in some embodiments some or all of the outer shaft 138, theintermediate shafts 140, 3000, 3002, and the inner shaft can havedifferent lengths. In some embodiments, for example, one or more of theintermediate shafts 140, 3000, 3002 can be relatively longer than theouter shaft 138, and in some embodiments, the inner shaft can berelatively longer than the intermediate shaft 140.

The thrombus extraction catheter 104 can further include a thrombusextraction device (TED). In some embodiments, the TED can connect to theintermediate shaft 140 and the inner shaft, and can be contained in anundeployed configuration within the lumen 802 of the outer shaft 138,and in some embodiments, the TED can connect to the first intermediateshaft 140 and one of the second intermediate shaft 3000, the thirdintermediate shaft 3002, and the inner shaft. In some embodiments, therelative positioning of the outer shaft 138, one or more of theintermediate shafts 140, 3000, 3002, and/or the inner shaft can resultin the TED being in an undeployed configuration, a deployedconfiguration, a partial expansion configuration, and/or a fullexpansion configuration. In some embodiments, the TED in the deployedconfiguration can be in either the full expansion configuration or inthe partial expansion configuration.

The handle 134 can include a distal end 142, also referred to herein asa lock end 142, and a proximal end 144, also referred to herein as aplunger end 144. In some embodiments, the intermediate shaft 140connects to, and distally extends towards the distal end 132 of thethrombus extraction catheter 104 from the distal end 142 of the handle134. In some embodiments, in which the TED includes an everted orpartially everted braided filament mesh structure, a handle is not usedto deploy or actuate the braided filament mesh structure. In some suchembodiments, the force of the clot against the braided filament meshstructure expands and/or deploys the braided filament mesh structurewhen the TED is retracted through the clot.

As seen in FIG. 1, the distal end 142 of the handle 134 can include alock feature 146 such as, for example, a spinlock. The lock feature 146can selectively engage and/or lockingly engage with a mating feature 148located on a proximal end 150 of the outer sheath 138. In someembodiments, for example, the outer sheath 138 can proximally slide overthe intermediate sheath 140 until the lock feature 146 engages with themating feature 148 to thereby secure the position of the outer sheath138 with respect to the intermediate sheath 140. In embodiments in whichthe intermediate shaft 146 is relatively longer than the outer shaft138, a portion of the intermediate shaft 146 distally extends from adistal end 152 of the outer shaft 138 when the outer shaft 138 islockingly engaged with the lock feature 146.

The handle 134 can include a plunger 154 that can be movable between afirst, non-extended position and a second, extended position. In someembodiments, the plunger 154 can be moved from the first position to thesecond position by proximally displacing the plunger 154 relative to thehandle 134. The plunger 154 can be lockable in one or both of the firstposition and/or the second position. In some embodiments, the plunger154 can be connected to one or several features of the TED that can lockthe TED in a full expansion configuration and/or move the TED to a fullexpansion configuration.

The plunger 154 can connect to one of: the second intermediate shaft3000; the third intermediate shaft 3002; and the inner shaft such thatthe connected one of: the second intermediate shaft 3000; the thirdintermediate shaft 3002; and the inner shaft is displaceable relative tothe handle 134, the outer shaft 138, and/or the intermediate shaft 140via the movement of the plunger 154 from the first position to thesecond position. In some embodiments in which the inner shaft isrelatively longer than the intermediate shaft 140 and/or the outer shaft138, the inner shaft can have a length such that the inner shaftdistally extends past a distal end of the intermediate shaft 140regardless of whether the plunger 154 is in the first position or thesecond position.

The thrombus extraction catheter 104 can further include a first flushport 155 connecting to the outer shaft 138 and a second flush port 156connecting to the handle 134. In some embodiments, the first flush port155 can be fluidly connected to the lumen 802 of the outer shaft 138 soas to allow the flushing of the lumen 802 of the outer shaft 138 via thefirst flush port 155. In some embodiments, the second flush port 156 canbe fluidly connected to an internal portion of the handle 134 andthereby the lumen of the intermediate shaft 140 so as to allow theflushing of the lumen of the intermediate shaft 140.

The thrombectomy system 100 can further include a loading funnel 158.The loading funnel 158 can include a funnel portion 160 and a shaftportion 162. The funnel portion 160 can define a funnel shaped interiorvolume connecting to a lumen of the shaft portion 162. The funnel shapedinterior volume can be sized and shaped to receive the self-expandingfunnel and to move the self-expanding funnel to a constrained positionas the self-expanding funnel is advanced through the funnel portion 160.The funnel shaped interior volume and the lumen can be sized to allowthe distal end 124 of the obturator 120 to pass completely through theloading funnel 158.

In some embodiments, the loading funnel 158 can be configured tofacilitate loading of the self-expanding funnel into the obturator 102.In some embodiments, the self-expanding funnel can be loaded byinserting the obturator 120 through the elongate member 106 such thatthe obturator 120 extends from the distal end 110 of the elongate member106 and beyond the self-expanding funnel. The loading funnel 158 canthen be proximally slid over the obturator 120 and the self-expandingfunnel until the self-expanding funnel is fully encapsulated by theloading funnel 158 and/or until the self-expanding funnel is in theconstrained configuration. The obturator 120 can then be retracted tothereby load and/or capture the self-expanding funnel within a portionof the obturator 120, and the loading funnel 158 can then be removedfrom the obturator 120 and the elongate member 106.

The thrombectomy system 100 can further include a sealed hub dilator170, also referred to herein as a seal dilator 170 and/or an aperturedilator 170. A section view of seal dilator 170 is shown in FIG. 1. Theseal dilator 170 can be sized and shaped for insertion into the sealedaperture 112 prior to removal of thrombus through the sealed aperture112. By this insertion into the sealed aperture 112, the seal dilator170 can dilate the sealed aperture 112. In some embodiments, thisdilation of the sealed aperture 112 can prevent the application of forcefrom the sealed aperture 112 onto the thrombus during removal of thethrombus through the sealed aperture 112. In some embodiments, the sealdilator 170 can comprise an insertion portion 172 configured tofacilitate the insertion of the seal dilator 170 into the sealedaperture 112. The seal dilator 170 can further comprise a body portion174 that can, alone, or together with the insertion portion 172 definean extraction lumen 176 through which the thrombus can be removed fromthe lumen 1701 of the elongate member 106. In some embodiments, theinternal diameter of the extraction lumen 176 can be larger than adiameter of the sealed aperture 112 in a sealed configuration

With reference now to FIG. 2, a side view of one embodiment of thethrombus extraction catheter 104 is shown. The thrombus extractioncatheter 104 includes the handle 134, the outer shaft 138, theintermediate shaft 140, the inner shaft 200, and the thrombus extractiondevice 202, also referred to herein as the TED 202. As shown in FIG. 2,the outer shaft 138 is proximally displaced relative to the handle 134such that the mating feature 148 of the outer shaft 138 is contactingthe locking feature 146 of the handle 134. Due to this positioning ofthe outer shaft 138 with respect to the handle 134, each of theintermediate shaft 140, the inner shaft 200, and the TED 202 distallyextend beyond a distal end 204 of the outer shaft 138. The thrombusextraction device 202 shown in FIG. 2 is in a deployed and partialexpansion configuration.

The thrombus extraction device 202 can include a self-expanding coringelement 206, and an expandable cylindrical portion 208. Theself-expanding coring element 206 can be relatively more proximallylocated on the thrombus extraction catheter 104 than the expandablecylindrical portion 208. The self-expanding coring element 206 caninclude a proximal end 210 connecting to a distal end 212 of theintermediate shaft 140 and a distal end 214 connecting to a proximal end216 of the expandable cylindrical portion 208. The distal end 217 of theexpandable cylindrical portion 208 can connect to a distal end 218 ofthe inner shaft 200.

In some embodiments, the distal end 218 of the inner shaft 200 canfurther include a tip 220 such as an atraumatic tip and/or a radiopaquemarker 222. In some embodiments, the tip 220 can include the radiopaquemarker 222. Further radiopaque markers can be located on, for example,the outer shaft 138 and specifically the distal end 204 of the outershaft 138 and/or the distal end 212 of the intermediate shaft 140. Insome embodiments, one or both of the distal end 204 of the outer shaft138 and the distal end 212 of the intermediate shaft 140 can eachcomprise a radiopaque marker. In some embodiments, the atraumatic tip220 can define a channel configured to allow the guidewire to passthrough the atraumatic tip 220.

With reference now to FIG. 3, a side view of one embodiment of thethrombus extraction catheter 104 with the thrombus extraction device 202in the deployed and full expansion configuration is shown. In contrastto the embodiment of FIG. 2, the plunger 154 is in the second position,proximally retracted from the handle 134, and the inner shaft 200 isthereby proximally retracted relative to the intermediate shaft 140 tothereby fully expand the expandable cylindrical portion 208 and tosecure the expandable cylindrical portion 208 and the self-expandingcoring element 206 in full expansion configurations and/or in fullexpansion.

The thrombus extraction catheter 104 can comprise one or severalfeatures configured to secure the thrombus extraction device 202, andspecifically the self-expanding coring element 206 and/or the expandablecylindrical portion 208 in a fully expanded position and/or in fullexpansion. As used herein, full expansion describes a condition in whichthe thrombus extraction device 202 is in a state of continual bias to ortoward expansion by one or several forces in addition to theself-expanding forces arising from the thrombus extraction device 202.In some embodiments, full expansion occurs when the thrombus extractiondevice 202 is deployed and when the plunger 154 is in the secondposition, or when the thrombus extraction device 202 is deployed andbiased towards expansion via a spring connected either directly orindirectly to the thrombus extraction device 202. In such an embodimentin which the thrombus extraction device 202 is biased towards expansionvia a spring, forces less than a minimal radial compressive force do notchange the diameter of the thrombus extraction device 202. In someembodiments, for example, the thrombus extraction device 202 at fullexpansion maintains at least a desired radial force on a blood vesselwhen the thrombus extraction device 202 is drawn through that bloodvessel. In some embodiments, one or several dimensions of the thrombusextraction device 202 can vary when the thrombus extraction device 202is in full expansion. In some embodiments, this can facilitateapposition of the walls of the blood vessel by the thrombus extractiondevice 202 and/or a desired force or force level applied to the walls ofthe blood vessel by the thrombus extraction device 202.

In some embodiments, the plunger 154 can be locked in the secondposition by, for example, rotating the plunger 154 with respect to thehandle 134 to thereby engage one or several locking features on theplunger 154 and in the handle 134. In some embodiments, by locking theplunger 154 in the second position, the thrombus extraction device 202,and specifically the self-expanding coring element 206 and/or theexpandable cylindrical portion 208 can be secured in the full expansionby securing the position of the inner shaft 200 with respect to theintermediate shaft 140. In some embodiments, securing the position ofthe inner shaft 200 with respect to the intermediate shaft 140 caninclude locking the inner shaft 200 with respect to the intermediateshaft 140 and/or coupling the position of the inner shaft 200 withrespect to the position of the intermediate shaft 140. In someembodiments, this locking and/or coupling can be static, referred toherein as statically locked and/or statically coupled, in that theposition of the inner shaft 200 is fixed with respect to the position ofthe intermediate shaft 140, and in some embodiments, this locking and/orcoupling can be dynamic, referred to herein as dynamically locked and/ordynamically coupled, in that the position of the inner shaft 200 withrespect to the intermediate shaft 140 is limited. In some embodiments,and as will be discussed at greater length below, the inner shaft 200can be dynamically locked to the plunger 154 via a compliance spring1214, which can be, for example, a tension spring or a compressionspring, which allows some movement of the inner shaft 200 with respectto the intermediate shaft 140 when the plunger is locked in the secondposition. Thus, in such an embodiment, the inner shaft 200 isdynamically locked and/or dynamically coupled to the intermediate shaft140 and/or with respect to the intermediate shaft 140.

With reference now to FIG. 4, a side view of one embodiment of theself-expanding coring element 206 is shown. The self-expanding coringelement 206 can comprise a variety of shapes and sizes and can be madefrom a variety of materials. In some embodiments, the self-expandingcoring element can be made from a shape memory material such as, forexample, a shape memory alloy and/or a shape memory polymer. In someembodiments, the self-expanding coring element 206 can comprise anitinol and/or a nitinol alloy. In some embodiments, the self-expandingcoring element 206 can comprise a braid that can, for example, form asemi-rigid collapsible structure.

The self-expanding coring element 206 can be made using a variety oftechniques including, for example, welding, laser welding, cutting,laser cutting, braiding, expanding, or the like. In some embodiments,the self-expanding coring element 206 can be laser cut from a piece ofnitinol such as, for example, a nitinol tube, after which theself-expanding coring element 206 can be blown up and/or expanded. Insome embodiment, the self-expanding coring element 206 can be laser cutnitinol, laser cut polymer tube, one or several wireform structures,metal or polymeric, or one or several injection molded polymericstructures. In some embodiments, the self-expanding coring element 206can be castellated nitinol wire braid, nitinol braided structure, lasercut nitinol, laser cut polymer tube, injection molded polymericstructure, an inflatable balloon, or one or several other metal orpolymeric structures.

The self-expanding coring element 206 can comprise a fenestratedstructure 400, which can be a unitary fenestrated structure, anon-unitary fenestrated structure, and/or a stent or a stent portionthat can be configured to core and separate a portion of a thrombus suchas a vascular thrombus from the blood vessel containing the thrombus.This fenestrated structure 400 can comprise a plurality of struts 402that together define a plurality of interstices 404. The struts cancomprise a variety of shapes and sizes, and in some embodiments, thestruts can have a thickness and/or diameter between approximately 0.05and 0.15 inches, between approximately 0.075 and 0.125 inches, betweenapproximately 0.09 and 0.1 inches, and/or of approximately 0.096 inches.

In some embodiments, the self-expanding coring element 206 can comprisea first region 406 and a second region 408. The second region 408 can begenerally tubular and can include a plurality of interconnected struts402. The first region 406, as seen in FIG. 5, can comprise a reducednumber of struts 402 as compared to the second region to facilitate thecollapse of the self-expanding coring element 206 to a non-expandedconfiguration and to maintain a coring orientation when the blood vesselis tortuous. In some embodiments, the first region can further comprisetwo curved struts 410-A, 410-B twisting in opposite directions around acentral axis 412, also referred to herein as a longitudinal axis 412, ofthe self-expanding coring element 206 to define a mouth 414 of theself-expanding coring element 206.

In some embodiments, the connection of the self-expanding coring element206 to the intermediate shaft 140 via the two curved struts 410-A, 410-Bcan improve the operation of the thrombus extraction device 202 byflexibly connecting the self-expanding coring element 206 to theintermediate shaft 140. Particularly, the removal of struts from region420 of the self-expanding coring element 206 allows the self-expandingcoring element 206 to flex about a connection member 415 located at theproximal end 210 of the self-expanding coring element 206 and connectingthe self-expanding coring element 206 to the intermediate shaft 140 ofthe thrombus extraction catheter 104. This ability to flex canfacilitate the maintenance of the coring orientation with the bloodvessel is tortuous. In some embodiments, such flexing of theself-expanding coring element 206 can result in the region 420functioning as the mouth 414.

As seen in FIG. 4, the curved struts 410 extend at an angle θ, alsoreferred to herein as a coring angle, relative to the central axis 412from a bottom 416 of the self-expanding coring element 206 towards thetop 418 of the self-expanding coring element 206. In some embodiments,this angle can be between 20 degrees and 50 degrees and/or between 30degrees and 45 degrees when fully expanded.

In some embodiments, the coring angle can either positively or adverselyaffect the operation of the TED 202. For example, too steep a coringangle can prevent the self-expanding coring element 206 from beingcollapsible and thus prevent the retraction of the self-expanding coringelement 206 into the introducer sheath 102. Additionally, too shallow acoring angle can result in the self-expanding coring element 206 tooeasily collapsing which can decrease the coring ability of theself-expanding coring element 206. In some embodiments, this decrease inthe coring ability of the self-expanding coring element 206 can resultin the self-expanding coring element 206 no longer effectively coringthrombus.

In some embodiments, the most proximal edge of the two curved struts410-A, 410-B, referred to herein as a leading edge 411, can be sharpenedand/or the leading edge 411 of the two curved struts 410-A, 410-B cancomprise a cutting element, knife, or the like

The self-expanding coring element 206 can comprise a variety of sizes.In some embodiments, the self-expanding coring element 206 can comprisea length, defined as the shortest distance between the proximal end 210of the self-expanding coring element 206 and the distal end 214 of theself-expanding coring element 206, of between approximately one and 3inches, between approximately 1.5 and 2.5 inches, between approximately1.75 and 2.25 inches, between approximately 1.9 2.0 inches, and/or ofapproximately 1.96 inches. In some embodiments, the self-expandingcoring element 206 can comprise a fully expanded diameter betweenapproximately 2 and 50 mm, between approximately 4 and 25 mm, betweenapproximately 6 and 20 mm, and/or between approximately 8 and 16 mm. Insome embodiments, the self-expanding coring element can be applied todebulking of an artery or vein such as, for example, the inferior venacava. In some embodiments, such debulking can be performed in responseto the occluding and/or partial occluding of one or several filters inthe inferior vena cava.

In some embodiments, the length and the diameter of the self-expandingcoring element 206 can be selected based on the size of the bloodvessel, and particularly the diameter of the blood vessel from whichthrombus is to be extracted. In some embodiments, the length of theself-expanding coring element 206 can be selected based on the fullyexpanded diameter of the self-expanding coring element 206 to preventundesired tipping and/or rotation of the self-expanding coring elementwithin the blood vessel and with respect to the blood vessel. As usedanywhere herein, “approximately” refers to a range of +/−10% of thevalue and/or range of values for which “approximately” is used.

With reference now to FIG. 7, a side view of one embodiment of thethrombus extraction device 202 is shown. As seen in FIG. 7, theself-expanding coring element 206 is connected via the connection member415 at the proximal end 210 of the self-expanding coring element 206 tothe distal end 212 of the intermediate shaft 140. The proximal end 216of the expandable cylindrical portion 208 connects to the distal end 214of the self-expanding coring element 206. In some embodiments, theexpandable cylindrical portion 208 and specifically the proximal end 216of the expandable cylindrical portion 208 is formed on the distal end214 of the self-expanding coring element 206 to thereby form a unitarythrombus extraction device 202. The distal end 217 of the expandingcylindrical portion 208 connects to the distal end 218 of the innershaft 200.

In some embodiments, and as seen in FIG. 7, the self-expanding coringelement 206 can engage with all or portions of the inner shaft 200 toaffect the expansion of the self-expanding coring element 206.Specifically, in some embodiments, the self-expanding coring element 206can include one or several features that can together form an expansionmechanism. 701. In some embodiments, the expansion mechanism 701 caninclude a ring 700, also referred to herein as a ring feature 700. Thering 700 can be the same material as the self-expanding coring element206 or can be a different material than the self-expanding coringelement 206. The ring 700 can be integrally formed with theself-expanding coring element 206 and/or can be attached to theself-expanding coring element via, for example, one or several welds,adhesive, one or several mechanical fasteners, or the like. The ring 700can have a diameter larger than the diameter of the inner shaft 200 suchthat the ring 700 is slidable along the inner shaft 200.

As further seen in FIG. 7, the expansion mechanism 701 can include astop 702 that can be located on one of the shafts such as, for example,one of: the second intermediate shaft 3000; the third intermediate shaft3002; and the inner shaft 200. In some embodiments, the stop 702 cancomprise a polymeric member and/or metallic member that is affixed to aportion of the inner shaft 200. The stop 702 can, in some embodiments,have the form of a tab, a protrusion, a flange, a ridge or the like. Insome embodiments, the stop 702 can be sized and shaped to engage withthe ring 700 to thereby apply proximally directed force to theself-expanding coring element 206 when shaft 200, 3000, 3002 to whichthe stop 702 is connected is proximally displaced via, for examplemovement of the plunger 154 to the second position and/or displacementof a shuttle moved according to a spring, such as a constant forcespring connected to the shuttle. In some embodiments, a portion of theself-expanding coring element 206 located between the ring 700 and theconnection member 415 can be forcibly expanded by the application ofthis proximally directed force to ring 700, thereby moving theself-expanding coring member 206 to full expansion. In anotherembodiment, the expansion mechanism 701 does not include the ring 700and the stop 702 is not attached the one of the intermediate shafts 140,3000, 3002, rather, the expansion mechanism 701 comprises a wire orfilament that can be, for example, a metallic or polymeric material. Thewire or filament wraps through the self-expanding coring element 206 andcan be attached such as fixedly attached to one of the shafts such as,for example, the outer shaft 138 of the thrombus extraction catheter104. In such an embodiment the stop 702 feature is engaged when theself-expanding coring element 206 is fully deployed by the wire orfilament creating tension on the self-expanding coring element 206. Insome embodiments, for example, the terminating end of the filament canbe fixed to one of the shafts such as, for example, the outer shaft 138of the thrombus extraction catheter 104 via a compression or tensionspring, which spring allows the self-expanding coring element 206 toreduce in diameter slightly without disengaging the stop 702. In someembodiments, the wire or filament is comprised of an elastic material toinclude the functionality of the compression or tension spring.

In some embodiments, the inner shaft 200 of the thrombus extractioncatheter 104 can be selectively connected to the distal end 217 of theexpandable cylindrical portion 208. This can allow the displacement ofthe inner shaft 200 to bring the self-expanding coring element 206 tofull expansion via the engagement of the ring feature 700 with the stop702. In some embodiments, and after the self-expanding coring element206 is at full expansion, the inner shaft 200 can be recoupled to thedistal end 217 of the expandable cylindrical portion 208 such that theexpandable cylindrical portion 208 is fully expanded and/or can berecoupled to the distal end 217 of the expandable cylindrical portion208 to compress the expandable cylindrical portion 208 when the plunger154 is moved from the second position to the first position.

In some embodiments, the expandable cylindrical portion 208 can comprisea braided filament mesh structure 704 that can be configured to capturethrombus. In some embodiments, the braided filament mesh structure canbe coextensive with the expandable cylindrical portion 208 and thus canshare a proximal end 216 and/or a distal end 217. In the embodimentshown in FIG. 7, the braided filament mesh structure 704 is a braid ofelastic filaments having a generally tubular, elongated portion 706 anda distal tapered portion 708. In other embodiments, the braided filamentmesh structure 704 can be any porous structure and/or can have othersuitable shapes, sizes, and configurations (e.g., the distal portion 708can be generally cylindrical, etc.).

Due to the connection of the braided filament mesh structure 704 to thedistal end 218 of the inner shaft 200, axial movement of the inner shaft200 radially expands/shortens or collapses/lengthens the braidedfilament mesh structure 704 of the TED 200. For example, so long as theintermediate shaft 140 is fixed and/or limited to axial movement at arate less than that of the inner shaft 200: (1) distal movement of theinner shaft 200 stretches the braided filament mesh structure 704 alongits longitudinal axis such that the radius of the braided filament meshstructure 704 decreases and the length of the braided filament meshstructure 704 increases; and (2) proximal movement of the inner shaft200 compresses the braided filament mesh structure 704 along itslongitudinal axis such that the radius of the braided filament meshstructure 704 increases and the length of the braided filament meshstructure 704 decreases. The filament mesh structure 704 can bepositioned in a plurality of configurations including, for example, astacked configuration, a collapsed configuration, and an expandedconfiguration. The filament mesh structure 704 in the stackedconfiguration can have a shorter length than the filament mesh structure704 in the expanded configuration, and the filament mesh structure 704in the expanded configuration can have a shorter length the filamentmesh structure 704 in the collapsed configuration. In certainembodiments, the braided filament mesh structure 704 can have anydesired length in the collapsed configuration, including, for example, alength in the collapsed configuration between approximately 1 and 80inches, between 2 and 60 inches, between 3 and 50 inches, betweenapproximately 5 and 30 inches, between approximately 10 and 20 inches,and/or of approximately 16 inches, and in some embodiments, the braidedfilament mesh structure 704 can have a length in the expandedconfiguration of between approximately 1 and 25 inches, betweenapproximately 10 and 20 inches, and/or of approximately 11 inches. Insome embodiments, the filament mesh structure 704 can have any desiredlength in the stacked configuration including, for example, a lengthbetween 1 and 50 inches, a length between 1 and 30 inches, a lengthbetween 1 and 20 inches, a length of between 1 and 15 inches, between 2and 10 inches, and/or of approximately 5 inches in the stackedconfiguration.

In some embodiments, the braid angles of the filament mesh structure 704can change between configurations. In some embodiments, for example, thefilament mesh structure 704 can be defined by a braid angle θ as shownin FIG. 7. The braid angle θ can be the angle between the wire/filament750 of the braid and the center line 752 of the braid. As the length ofthe filament mesh structure 704 increases, the braid angle θ candecrease, and as the length of the filament mesh structure 704decreases, the braid angle θ can increase. In some embodiments, thebraid angle θ of the filament mesh structure 704 can be less thanapproximately 10°, less than approximate 20°, less than approximately30°, less than approximately 40°, and/or less than approximately 50°when the filament mesh structure 704 is in the collapsed configuration.In some embodiments, the braid angle of the filament mesh structure 704can be between 20° and 85°, between 30° and 70°, between 35° and 60°,between 40° and 50°, and/or approximately 45° when the filament meshstructure 704 is in the expanded configuration. In some embodiments, thebraid angle of the filament mesh structure 704 can be greater thanapproximately 45°, greater than approximately 60°, greater thanapproximately 70°, and/or greater than approximately 80° when thefilament mesh structure 704 is in the stacked configuration.

In some embodiments, the braided filament mesh structure 704 can beformed by a braiding machine and/or weaving machine, and in someembodiments, the braided filament mesh structure 704 can be manuallybraided and/or woven. It can be advantageous to utilize a braidingmachine and/or weaving machine that does not employ bobbins or otherfilament spooling mechanisms, typical of many conventional braiders asthey make forming the braid onto the self-expanding coring element 206significantly more difficult. Braiding machine and/or weaving machinewhere the filaments are free-hanging allow for much easier loadingdirectly onto the self-expanding coring element 206. In someembodiments, the braided filament mesh structure 704 can be braidedusing methods or devices contained in some or all of: U.S. Pat. No.8,833,224, entitled “BRAIDING MECHANISM AND METHOD OF USE”, and filed onMay 8, 2013; U.S. Pat. No. 8,826,791, entitled “BRAIDING MECHANISM ANDMETHOD OF USE”, and filed on Sep. 10, 2012; U.S. Pat. No. 8,261,648,entitled “BRAIDING MECHANISM AND METHOD OF USE”, and filed on Oct. 17,2011; U.S. Pat. No. 8,820,207, entitled “BRAIDING MECHANISM AND METHODOF USE”, and filed on Apr. 26, 2013; U.S. Patent Publication No.2016/0030155, entitled “ANEURYSM GRAFT WITH STABILIZATION”, and enteringthe U.S. National Phase on Sep. 14, 2015; and U.S. Patent PublicationNo. 2014/0318354, entitled “BRAIDING MECHANISM AND METHOD OF USE”, andfiled on Jul. 11, 2014; the entirety of each of which is herebyincorporated by reference herein.

In some embodiments, the braided filament mesh structure 704 may beformed as a tubular braid, which tubular braid may then be furthershaped using a heat setting process. In some embodiments, the braid maybe a tubular braid of fine metal wires such as nitinol (nickel-titaniumalloy), platinum, cobalt-chrome alloy, stainless steel, tungsten ortitanium. In some embodiments, the braided filament mesh structure 704can be formed at least in part from a cylindrical braid of elasticfilaments. Thus, the braid may be radially constrained without plasticdeformation and will self-expand on release of the radial constraint.Such a braid of elastic filaments is herein referred to as a“self-expanding braid.”

In some embodiments, the thickness of the braid filaments can be lessthat about 0.15 mm. In some embodiments, the braid may be fabricatedfrom filaments and/or wires with diameters ranging from about 0.05 mm toabout 0.25 mm. In some embodiments, braid filaments of differentdiameters may be combined to impart different characteristics including:stiffness, elasticity, structure, radial force, pore size, emboliccapturing or filtering ability, etc. In some embodiments, the braidedfilament count is between 20 and 80, is greater than 30, and/or isapproximately 24. Pore sizes of the braided mesh in the elongatedportion 706 may be in the range of about 0.4 mm to 4.0 mm. In someembodiments, the pore size may be in the range of 0.5 mm to 2.5 mm.

In some cases thrombus may form a shape that is difficult to retractinto the introducer sheath 102 when thrombus is within the braidedfilament mesh structure 704. Such a case is depicted in FIG. 8 in whichthe thrombus extraction device 202, and specifically the braidedfilament mesh structure 704, is partially retracted into the introducersheath 102. As depicted in FIG. 8, thrombus 800 has formed a ball thathas a diameter larger than the diameter of the introducer sheath 102.Such behavior by the thrombus 800 can prevent the removal of the TED 200and the thrombus 800 from the patient's body. FIGS. 9 and 10 addressfeatures to prevent such behavior by the thrombus.

FIG. 8 further shows a cross-section view of the elongate member 106such that the lumen 1702 of the elongate member is visible, across-section of the outer shaft 138 such that the lumen 802 of theouter shaft 138 is visible, and a cross-section of the intermediateshaft 140 such that the lumen 804 of the intermediate shaft 140 isvisible.

With reference now to FIG. 9, a side view of one embodiment of thebraided filament mesh structure 704 comprising multiple pore sizes isshown. As seen, the braided filament mesh structure 704 comprises afirst portion 900 comprising a first plurality of pores 904 and a secondportion 902 comprising a second plurality of pores 906. In someembodiments, the first portion 900 can correspond to the elongatedportion 706, and the second portion 902 can correspond to the distaltapered portion 708.

As shown in FIG. 9, the first portion 900 of the braided filament meshstructure 704 is relatively more proximal than the second portion 902.As further shown, the pores in the first plurality of pores 904 of thefirst portion 900 are smaller than the pores in the second plurality ofpores 906 of the second portion 902. In some embodiments, the largerpores of the distal, second portion 902 can have an average size greaterthan or equal to 1.5 mm, and in some embodiments, between approximately1.0 mm and 4.0 mm.

In such an embodiment, the larger size of the pores of the secondplurality of pores 906 can allow and/or facilitate the extrusion ofportions of the thrombus when the braided filament mesh structure 704 ismoved to the unexpanded configuration and/or when the braided filamentmesh structure 704 is retracted into the introducer sheath 102. In someembodiments, this extrusion of portions of the thrombus can prevent thecase in which the thrombus cannot be retracted into the introducersheath 102. Further, in some embodiments, relatively newer portions ofthrombus can be extruded before relatively older portions of thrombus asrelatively newer portions of thrombus can be softer and/or moremalleable. These relatively newer portions of the thrombus can then becaptured and/or broken down by features of the introducer sheath 102.

In some embodiments, and as seen in FIG. 9, the braided filament meshstructure 704 can transition from the first portion 900 to the secondportion 902 by the longitudinal overlaying of one or several first wires910 or first filaments 910 with one or several second wires 912 orsecond filaments 912. In some embodiments, for example, a first wire 910can be longitudinally overlaid with a second wire 912 thereby forming awire pair 914. In some embodiments, the first and second wires 910, 912forming the wire pair 914 can then be woven as a single wire to therebyincrease the pore size in portions of the braided filament meshstructure 704 woven with the wire pair 914. In some embodiments, forexample, the first portion 900 can comprise a 48 wire mesh. In thesecond portion 902, one-half of the wires or filaments forming the48-wire mesh can be first wires 910 and the other half of the wires orfilaments forming the 48-wire mesh can be second wires 912. Each of thefirst wires 910 can be longitudinally overlaid by one of the secondwires 912, thereby forming 24 wire pairs 914. These wire pairs 914 canthen be woven to form a 24-wire mesh having a larger pore size than the48-wire mesh.

With reference now to FIG. 10, a side view of one embodiment of the TED200 comprising a plurality of circumferential depressions 1000, alsoreferred to herein as circumferential grooves, radial ribs, and/orradial grooves, is shown. In some embodiments, some or all of thisplurality of circumferential depressions 1000 can inwardly extendtowards a central axis 1002 and/or midline 1002 of the thrombusextraction device 202. In some embodiments, the plurality ofcircumferential depressions 1000 can be longitudinally spaced and/orequally spaced along the length of the expandable cylindrical portion208 and/or the braided filament mesh structure 704 between the proximalend 216 and the distal end 217 of the cylindrical portion 208 and/or thebraided filament mesh structure 704. In some embodiments, thesecircumferential depressions 1000 can, when the thrombus extractiondevice 202 is moved from an expanded configuration to an unexpandedconfiguration, engage with portions of the thrombus contained within thecylindrical portion 208 and/or the braided filament mesh structure 704to inhibit movement of the thrombus with respect to one or both of theproximal end 216 and the distal end 217 of the cylindrical portion 208and/or the braided filament mesh structure 704. This inhibition ofthrombus movement can decrease the likelihood of the creation ofthrombus that cannot be retracted into the introducer sheath 102.

Although depicted in separate figures, some embodiments of the thrombusextraction device 202 can include both the plurality of circumferentialdepressions discussed with respect to FIG. 10 and multiple pore sizes asdiscussed with respect to FIG. 9.

With reference now to FIG. 11, a schematic illustration of oneembodiment of a weaving pattern for forming the cylindrical portion 208and/or the braided filament mesh structure 704 onto the self-expandingcoring element 206 at one or several formation points 1103 is shown. Asseen, the self-expanding coring element 206 comprises a plurality ofstruts 402 that connect at formation points 1103 comprising peaks 1100,also referred to herein as peak struts 1100. As seen, each of the peaks1100 is formed by the intersection of a first strut 402-A and a secondstrut 402-B, which intersecting struts 402-A, 402-B form a peak aperture1101.

In some embodiments, the self-expanding coring element 206 can comprisea plurality of peaks 1100 extending around the distal end of theself-expanding coring element 206. The plurality of peaks 1100 cancomprise 4 peaks 1100, 6 peaks 1100, 8 peaks 1100, 10 peaks 1100, 12peaks 1100, 16 peaks 1100, 20 peaks 1100, 24 peaks 1100, between 4 and50 peaks, between 8 and 20 peaks, and/or any other or intermediatenumber of peaks.

The cylindrical portion 208 and/or the braided filament mesh structure704 can comprise a plurality of filaments 1102 woven and/or braidedtogether to form the cylindrical portion 208 and/or the braided filamentmesh structure 704. In some embodiments, the plurality of filaments caninclude, for each of the peaks 1100 of the self-expanding coring element206, a first filament 1104 and the second filament 1106. The first andsecond filaments 1104, 1106 can be woven and/or braided onto theirrespective peak. In some embodiments, the first and second filaments1104, 1106 can be woven and/or braided onto their respective peak suchthat one or both of the first and second filaments 1104, 1106 form aloop about their respective peak. Thus, in some embodiments, the onlythe first filament 1104 forms a look about its peak, only the secondfilament 1106 forms a loop about its peak, or both the first and secondfilaments 1104, 1106 form loops about their peak. With reference to theembodiment of FIG. 11, the first filament 1104 can be inserted straightthrough the peak aperture 1101 of its peak such that the first filament1104 does not loop on itself directly adjacent to its peak, and morespecifically, directly distal of its peak.

The first filament 1104 can be inserted through the peak aperture 1101of its peak 1100 such that the first filament 1104 passes, when lookingfrom the outside of the self-expanding coring element 206 towards theinside of the self-expanding coring element 206, on top of the firststrut 402-A and under the second strut 402-B.

The second filament 1106 can be inserted through the peak aperture 1101of its peak such that the portion of the second filament 1106 passingthrough the peak aperture 1101 is separated from the peak by the firstfilament 1104. Further, the second filament 1106 can be inserted throughthe peak aperture 1101 such that the second filament 1106 passesunderneath the first strut 402-A and over the second strut 402-B. afterinsertion through the peak aperture 1101, the second filament 1106 canbe looped on itself to form a loop 1108 directly distal to its peak 100.

In some embodiments, because each filament 1104, 1106 is insertedthrough a peak aperture 1101, each filament 1104, 1106 can be treated,for braiding or weaving purposes as comprising a first wire extendingfrom its peak 1100 to a first end of the filament 1104, 1106 and asecond wire extending from its peak to a second end of that filament1104, 1106. Thus, in some embodiments in which the self-expanding coringportion 206 comprises 12 peaks, the cylindrical portion 208 and/or thebraided filament mesh structure 704 can be formed from 24 filaments1104, 1106 which can be woven and/or braided as 48 wires to form a 48wire mesh and/or weave.

In some embodiments, the cylindrical portion 208 and/or the braidedfilament mesh structure 704 can be braided/woven by, identifying theplurality of formation points 1103 formed by some of the struts 402 ofthe self-expanding coring element 206. Unique pairs of wires can bethreaded through each of the formation points 1103, and specificallythrough the peak aperture 1101 adjacent to each of the formation points1103. In some embodiments, each unique pair of wires can comprise afirst wire 1104 and a second wire 1106 overlaying the first wire 1104.The first and second wires can then be woven and/or braided into anet-like filament mesh structure of the cylindrical portion 208 and/orthe braided filament mesh structure 704 from the unique pairs of wiressuch that the first wires 1104 do not form loops about the formationpoints 1103 through which the first wires 1104 are threaded and suchthat the second wires 1106 form loops 1108 about the formation points1103 through which the second wires 1106 are threaded.

With reference now to FIG. 12, a section view of an embodiment of thehandle 134 in which the plunger 154 is in the first position is shown,and with reference to FIG. 13 a section view of an embodiment of thehandle 134 in which the plunger 154 is in the second position is shown.The handle 134 can include a housing 1200 that defines an internalvolume 1202. A plunger shaft 1204 can extend through all or portions ofthe internal volume 1202 and can connect to the shaft connecting and/orcoupled to some or all of the expansion features including portions ofthe expansion mechanism 701 such as, for example, the ring 700 or thestop 702. In some embodiments, this shaft can include, for example, thesecond intermediate shaft 3000, the third intermediate shaft 3002, orthe inner shaft 200, which inner shaft 200 can define the previouslyreferenced lumen 1400, also referred to herein as inner shaft lumen1400. The plunger shaft 1204 can terminate at a plunger guide 1208 thatis affixed to the plunger shaft 1204. In some embodiments, and as seenin FIGS. 12 and 13, the plunger 154 can be biased towards a firstposition by a plunger spring 1209 which can engage a portion of thehandle 134 and the plunger guide 1208. Thus, the plunger spring 1209 isless compressed when the plunger 154 is in the first position as isshown in FIG. 12, and the plunger spring 1209 is more compressed whenthe plunger 154 is in the second position as is shown in FIG. 13. Insome embodiments, this bias towards the first position can create a biasin the thrombus extraction device 202 towards the partial expansionconfiguration.

As seen in FIG. 14, a close-up view of the encircled portion “A”indicated in FIG. 13, the plunger guide 1208 can be positioned between aproximal stop 1210 and a distal stop 1212, which proximal stop 1210 andwhich distal stop 1212 can be each affixed to the shaft connectingand/or coupled to some or all of the expansion features, which shaft caninclude, for example, the second intermediate shaft 3000, the thirdintermediate shaft 3002, or the inner shaft 200 including the innershaft lumen 1400. The plunger guide 1208 can be dynamically connected tothe proximal stop 1210 via a stent compliance spring 1214, also referredto herein as a compliance spring 1214. In some embodiments, the use ofthe compliance spring 1214 to connect the plunger guide 1208 and theproximal stop 1210 can allow a change in the diameter of theself-expanding coring element 206 according to compressive forcesapplied to the self-expanding coring element 206.

In some embodiments, for example, via the interaction of the ringfeature 700 and the stop 702, radial compressive forces applied to theself-expanding coring element 206 can be transferred from theself-expanding coring element 206 via the ring feature 700 and the stop702 to the compliance spring 1214. In embodiments in which thecompressive force is greater than the spring force, the compliancespring 1214 can be compressed and the shaft connecting and/or coupled tosome or all of the expansion features, which shaft can include, forexample, the second intermediate shaft 3000, the third intermediateshaft 3002, or inner shaft 200 can distally advance relative to theintermediate shaft 140 to thereby reduce the diameter of theself-expanding coring element 206 until the compressive force is equalto the spring force. This compliance achieved via the compliance spring1214 enables use of the thrombus extraction catheter 104 in bloodvessels that can be arteries or venous vessels of non-constant diameterwhile maintaining desired contact of the self-expanding coring element206 on the walls of the blood vessels, veins, or venous vessels. In someembodiments, this compliance can result in a constant outward forceapplied to the vessel walls by the self-expanding coring element 206when the vessel has a diameter between approximately 1 and 30 mm, 2 and25 mm, 5 and 20 mm and/or any other or intermediate diameter. In someembodiments, this constant outward force can be constant in that thisoutward force is within a predetermined range. In some embodiments, forexample, the outward force can be approximately 5 N when the diameter ofthe self-expanding coring element 206 is approximately 20 mm and theoutward force can be approximately 20 N when the diameter of theself-expanding coring element 206 is approximately 5 mm. Thus, in someembodiments, a locking mechanism which can include the plunger 154 andthe compliance spring 1214 can be configured to maintain a desiredradial force on a vessel wall when the stent is compressed by thatvessel wall. In some embodiments, this desired force can be a sufficientradial force on the vessel wall to core and/or separate all or portionsof thrombus from the vessel wall when the self-expanding coring element206 is at full expansion.

With reference now to FIGS. 15 and 16, side views of embodiments of theobturator 120 are shown. As seen, the obturator 120 includes theproximal end 122, the distal end 124, and the elongate shaft 126. Asfurther seen, the obturator 120 can include a capture sheath 1500proximally extending form the distal end 124 of the obturator 120.

The Obturator 120 can further comprise a tip such as an atraumatic tip1502 located at the distal end 124 of the obturator 120. In someembodiments, the atraumatic tip 1502 can be radiopaque. The obturator120 can further include a connection fitting 1504 that can be located ata proximal end 1506 of the capture sheath 1500. In some embodiments, theconnection fitting 1504 can be configured to sealingly connect with thedistal end 110 of the elongate sheath 106 of the introducer sheath 102.

The obturator 120 can further include a stop portion 1508 located at theproximal end 122 of the obturator 120. In some embodiments, the stopportion 1508 can have a diameter larger than the lumen 1701 of theelongate member 106 of the introducer sheath 102 and/or larger than thediameter of the sealed aperture 112 located at the proximal end 108 ofthe introducer sheath 102 so as to prevent the stop portion 1508 fromentering into the lumen 1701 of the elongate member 106 and/or thesealed aperture 112.

In some embodiments, the elongate shaft 126 can comprise a constant sizeand/or diameter, and in some embodiments, the elongate shaft 126 cancomprise multiple sizes and/or diameters. For example, the diameter 1510of the elongate shaft 126 shown in FIG. 15 is constant along the lengthof the elongate shaft 126. In contrast, the elongate shaft 126 shown inFIG. 16 has at least a first diameter 1512 along one or several firstportions 1513 of the elongate shaft 126 and a second diameter 1514 alongone or several second portions 1515 of the elongate shaft 126.

In some embodiments, the one or several second portions 1515 of theelongate shaft can be located along the length of the elongate shaft 126such, that when the obturator 120 is received within the elongate member106 of the introducer sheath 102 and positioned so that the connectionfitting 1504 seals with the distal end 110 of the elongate sheath 106,the one or several second portions 1515 extend through the sealedaperture 112. In such an embodiment, the second diameter 1514 can beselected such that the one or several second portions do not contactand/or dilate the sealed aperture 112 and/or a seal within the sealedaperture 112. Because such an embodiment of the obturator 120 does notdilate the seal of the sealed aperture 112 when the one or severalsecond portions extend through the sealed aperture 112, the introducersheath 102 can be stored, package, and/or sold with such an obturator120 pre-positioned extending through the lumen 1701 of the elongatemember 106.

With reference now to FIG. 17, a detailed section view of one embodimentof the capture sheath 1500 is shown. As seen, the capture sheath 1500includes the atraumatic tip 1502 and is connected to the elongate shaft126 of the obturator 120, which elongate shaft 126 extends through alumen 1701 of the elongate member 106. As further seen, a lumen 1700extends through the atraumatic tip 1502 and the elongate shaft 126,which lumen 1700 can be configured to receive a guidewire.

That capture sheath 1500 includes a capture shell 1702 that distallyextends from the atraumatic tip 1502 to the proximal end 1506 of thecapture sheath 1500. The capture shell 1702 terminates in the connectionfitting 1504. The capture shell 1702 has an internal diameter 1704 thatis greater than a diameter 1706 of the portion of the elongate shaft 126extending through the capture shell 1702. Due to the larger internaldiameter 1704 of the capture shell 1500, a receiving space is createdbetween the capture shell 1702 and the portion of the elongate shaft 126extending through the capture shell 1702. In some embodiments, thisreceiving space can be sized and shaped to receive and/or retain aself-expanding funnel 1708 in a constrained configuration. In someembodiments, the self-expanding funnel 1708 can have a diameter matchingthe internal diameter 1704 of the capture shell 1702 when theself-expanding funnel 1708 is in the constrained configuration. In someembodiments, this diameter of the self-expanding funnel can be less thanor equal to a diameter 1716 of the elongate member 106.

The self-expanding funnel 1708 can comprise a variety of shapes andsizes and can be made from a variety of materials. In some embodiments,the self-expanding funnel 1708 can have a maximum diameter greater thanand/or equal to the diameter of the self-expanded coring element 206 infull expansion, and in some embodiments, the self-expanding funnel 1708can have a minimum diameter equal to the diameter 1716 of the elongatemember 106 and/or to the diameter of the lumen 1701 of the elongatemember 106. In some embodiments, the self-expanding funnel 1708 can havea length greater than and/or equal to the length of the self-expandingcoring element 206 such that the self-expanding coring element 206 canbe received and contained within the self-expanding funnel 1708.

In some embodiments, the self-expanding funnel 1708 can have a conicallyshaped portion, and specifically, a truncated-conically shaped portion.In some embodiments, the self-expanding funnel can be formed from atleast one of a castellated nitinol braid, a nitinol braided stent, alaser cut nitinol, a laser cut polymer tube, an injection moldedpolymeric structure, or an inflatable balloon. In some embodiments, theself-expanding funnel 1708 can comprise a mesh having a pore sizesufficiently small to prevent the passage of dangerous thrombus throughthe pores of the mesh. In some embodiments, the self-expanding funnel1708 can be permeable to blood.

With reference now to FIGS. 18 through 20, side views of embodiments ofthe introducer sheath 102 in different configurations are shown. In FIG.18 the introducer sheath 102 is shown in an undeployed configuration, inFIG. 19, the introducer sheath 102 is shown in a partially deployedconfiguration, and in FIG. 20, the introducer sheath 102 is shown in afully deployed and/or deployed configuration.

Specifically, as seen in FIG. 18, the obturator 120 extends through thelumen 1701 of the elongate member 106 and the self-expanding funnel 1708is contained in a constrained configuration within the capture sheath1500. In FIG. 19, the obturator 120 has been distally advanced tothereby release the self-expanding funnel 1708 from the constrainedconfiguration and/or to deploy the self-expanding funnel 1708. In someembodiments, the length of the obturator 120, and specifically thelength of the elongate shaft between the proximal end of the capturesheath 1500 and the stop portion 1508 is sufficient to allow thedeployment of the self-expanding funnel 1708 from the capture sheath1500 before further distal movement of the obturator 120 is prevented bythe collision of the stop portion 1508 with the sealed aperture 112.

After the self-expanding funnel 1708 has been deployed, the obturator120 can be proximally retracted through the lumen 1701 of the elongatemember 106 and the sealed aperture 112 and can be removed from theintroducer sheath 102. After the obturator 120 has been removed from theintroducer sheath 102, the introducer sheath is in the fully deployedconfiguration as shown in FIG. 20.

In some embodiments, and as seen in FIG. 21, the introducer sheath 102can include an inflatable balloon 2100 located at, or proximate to thedistal end 110 of the elongate member 106. In some embodiments, theballoon 2100 can comprise a conically shaped internal portion 2102 thatcan be sized and shaped to receive the thrombus extraction device 202,and specifically that can have a length greater than or equal to thelength of the self-expanding coring element 206.

With reference now to FIG. 22, an introduction technique for accessingthe thrombus 2200 is shown. As depicted, the thrombus 2200 can belocated in a blood vessel and accessed through an access site 2260 suchas the popliteal access site or other venous or arterial access sites.The introducer sheath 102 can extend from the popliteal access site2260, or other venous or arterial access sites, to the deploymentposition 2262 at which the self-expanding funnel 1708 can be deployedand which can be proximate to the thrombus 2200. The TED 202 can bepassed through the clot 2200 in the direction of blood flow and the TED202 can be retracted through the clot 2200 in a direction opposite bloodflow. The retraction of the TED 202 through the clot 2200 can result inthe coring of the clot with the self-expanding coring element 206 andthe capturing of the clot in the expandable cylindrical 208.

In some such embodiments, all or portions of the TED 202 can extend intoone of the iliac veins and/or the inferior vena cava as depicted in FIG.23. Further, as the TED 202 is retracted from a proximal position withrespect to the heart to a distal position with respect to the heart, thediameter of the blood vessel 2202 will decrease as the TED 202 isretracted towards the access site 2260. This can result in increasedcompressive forces on the TED 202, and specifically on theself-expanding coring element 206. These compressive forces can betransferred via the ring feature 700 and the stop 702 to the compliancespring 1214. Via the stretching or compressing of the compliance spring1214, the diameter of the TED 202 and specifically of the coring element206 can change to match the diameter of the blood vessel and a desiredradial force, and/or force level can be maintained.

FIGS. 23-A to 23-H, FIGS. 24-A and 24-B, FIGS. 25-A to 25-H, FIGS. 34-Ato 34-H, FIGS. 41-A to 41-F, and FIGS. 42-A and 42-B depict processesfor using the thrombus extraction system 100 to remove thrombus from apatient's body, and specifically from a blood vessel, which can be avenous vessel, in the patient's body. This can includes: accessing theblood vessel via one or several percutaneous access sites that canprovide direct access to the blood vessel or indirect access to theblood vessel via one or several other blood vessels; advancing theintroducer sheath to a position proximate to the thrombus; deploying theself-expanding funnel of the introducer sheath; advancing the distal end132 of the thrombus extraction catheter 104 to a position proximate tothe thrombus; deploying the thrombus extraction device 202; capturingthe thrombus in the thrombus extraction device 202 by retracting thethrombus extraction device 202 through the thrombus; collapsing thethrombus extraction device 202; and removing the thrombus extractiondevice 202 and the captured thrombus from the introducer sheath 102 andfrom the patient's body. In some embodiments, these one or severalaccess sites can include, for example, a popliteal access site, afemoral access site, a mid-femoral access site, a tibial access site, acontralateral access site, an internal jugular access site, and/or othervenous or arterial access sites. In some embodiments, a thrombolyticagent can be infused and/or aspirated into or from the blood vesselbefore, during, or after the removal or extraction of the thrombus. Thisthrombolytic agent can comprise, for example, a tissue plasminogenactivator (TPA) or other clot dissolving medication.

In any of the herein disclosed embodiments, the device and/or deliverysystem may be adapted to deliver energy to the device and thrombus ortissue surrounding the device at the treatment site for the purpose offacilitating removal of thrombus or healing of tissue adjacent thedevice or both. In some embodiments, energy may be delivered through adelivery system to the device for treatment of a patient's vasculaturesuch that the device is heated or actuated by the energy. Examples ofenergy that may be delivered include but are not limited to lightenergy, thermal energy, vibration energy, electromagnetic energy, radiofrequency energy and ultrasonic energy. For some embodiments, energydelivered to the device may trigger the release of chemical or biologicagents to promote separation of thrombus from the vessel wall and/or toa patient's tissue for treatment of a patient's vasculature, healing oftissue disposed adjacent such a device or a combination thereof.

The process for using the thrombus extraction system 100 shown in FIGS.22-A to 22-H, FIGS. 24-A and 24-B, FIGS. 25-A to 25-H, FIGS. 34-A to34-D, FIGS. 41-A to 41-F, and FIGS. 42-A and 42-B can be performed withthe direction of blood flow or against the direction of blood flow.Thus, in some embodiments, the direction of blood flow in FIGS. 22-A to22-H, FIGS. 24-A and 24-B, FIGS. 25-A to 25-H, FIGS. 34-A to 34-D, FIGS.41-A to 41-F, and FIGS. 42-A and 42-B, can be from left to right, orfrom right to left.

With reference now to FIGS. 23-A to 23-H, a process for expanding thethrombus extraction device 202 in a blood vessel such as a venous vesselis shown. The process for expanding the thrombus extraction device 202in the vessel can be performed using all or portions of the thrombusextraction system 100. In some embodiments, the process for expandingthe thrombus extraction device 202 in the vessel can be performed inconnection with a monitoring technique, such as fluoroscopy,angiography, and/or ultrasonic monitoring. In some embodiments, themonitoring technique can be used to monitor the deployment of the TED202 in the vessel via observation of the one or several radiopaquemarkers located on the introducer sheath 102 and/or the thrombusextraction catheter 104.

The process begins at FIG. 23-A, wherein a thrombus 2200 is identifiedin a blood vessel 2202 such as venous vessel. In some embodiments, thethrombus 2200 can be located in the peripheral vasculature of thepatient's body. The thrombus 2200, also referred to herein as a clot2200, can comprise a proximal end 2204 and the distal end 2206. In someembodiments, the identification of the blood vessel 2202 can furtherinclude the determination of whether the thrombus 2200 in the bloodvessel 2202 is suitable for thrombus extraction. In some embodiments,the thrombus 2200 in the blood vessel 2202 can be suitable forextraction when the blood vessel 2202 has a diameter of at least 5millimeters. In some embodiments, the thrombus 2200 in the blood vessel2202 can be suitable for extraction when the blood vessel 2202 has adiameter of at least 5 millimeters and is at least one of a femoralvein, an iliac vein, a popliteal vein, a posterior tibial vein, ananterior tibial vein, or a peroneal vein.

After the thrombus has been identified, the process proceeds to the stepshown in FIG. 23-B, wherein the introducer sheath 102 is advanced,either with or against the direction of blood flow in the blood vessel,such that the distal end 110 of the introducer sheath 102 and/or theobturator 120 is proximate to the thrombus 2200, and particularly isproximate to the thrombus 2200 at a position proximal of the thrombus2200. In some embodiments, this can include providing the introducersheath 102 and percutaneously accessing the circulatory system of thepatient and specifically a blood vessel or venous vessel of the patientvia an access site 2208 which can be one of the above referenced accesssites.

After the introducer sheath 102 has been advanced to a desired position,the self-expanding funnel 1708 can be deployed and/or unsheathed fromthe constrained configuration to the expanded configuration as depictedin FIG. 23-C. In some embodiments, the self-expanding funnel 1708 can bedeployed by the relative distal movement of the obturator 120 withrespect to the elongate member 106 until the funnel 1708 is no longerconstrained by the capture sheath 1500 and then the obturator 120 can beproximally retracted through the lumen 1701 of the elongate member 106until the obturator 120 is removed from the introducer sheath 102.

In some embodiments, the relative distal movement of the obturator 120with respect to the elongate member can comprise fixing the position ofthe obturator 120 relative to the blood vessel 2202 and proximallyretracting the elongate member 106 over the obturator 120 to unsheathethe self-expanding funnel 1708 until the stop 1508 contacts the sealedaperture 112 and/or until monitoring, which can be fluoroscopicmonitoring, of radiopaque markers located in, for example, the tip 1502of the obturator 120 and the distal end 110 of the elongate member 106indicate that the self-expanding funnel 1708 is deployed and/or is nolonger constrained by the capture sheath 1500. Alternatively, in someembodiments, the relative distal movement of the obturator 120 withrespect to the elongate member can comprise fixing the position of theelongate member 106 relative to the blood vessel 2202 and distallyadvancing the obturator 120 two unsheathe the self-expanding funnel 1708until the stop 1508 contacts the sealed aperture 112 and/or untilmonitoring, which can be fluoroscopic monitoring, of radiopaque markerslocated in, for example, the tip 1502 of the obturator 120 and thedistal end 110 of the elongate member 106 indicate that theself-expanding funnel 1708 is deployed and/or is no longer constrainedby the capture sheath 1500.

After the self-expanding funnel 1708 has been deployed, a portion of thethrombus extraction catheter 104 such as the outer shaft 138 can beinserted into the lumen 1701 of the introducer sheath 102 via the sealedaperture 112 as depicted in FIG. 23-D. In some embodiments, this caninclude providing the thrombus extraction catheter 104 which comprisesthe thrombus extraction device 202. In some embodiments, the thrombusextraction device 202 can be constrained within the outer shaft 138 andcan inserted, together with the outer shaft 138, into the lumen of theelongate member 106 via the sealed aperture 112. In some embodiments,the outer shaft 138 of the thrombus extraction catheter 104 can have adiameter so as to dilate the seal of the sealed aperture 112 such thatthe sealed aperture 112 seals around and seals to the outer shaft 138.

After the outer shaft 138 has been inserted into the lumen 1701 of theintroducer sheath 102, a portion of the thrombus extraction catheter 104can be inserted via the introducer sheath 102 into the blood vessel 2202as depicted in FIG. 23-E. In some embodiments, the distal end 132 of thethrombus extraction catheter 104 can be advanced to a position proximateto the thrombus 2200 and/or to a position proximal to the thrombus 2200.In some embodiments, the insertion and/or advance of the thrombusextraction catheter 104 can be monitored and specifically can befluoroscopically monitored. In some embodiments, the position of one orseveral radiopaque markers, including radiopaque marker 222 of thethrombus extraction catheter 104 can be monitored.

After the portion of the thrombus extraction catheter 104 has beeninserted into the blood vessel 2202, a portion of the thrombusextraction catheter 104 can be distally advanced through the clot 2200as depicted in FIG. 23-F. In some embodiments, this distal advancethrough the clot 2200 can be either with or against the direction ofblood flow. In some embodiments, the portion of the thrombus extractioncatheter 104 distally advanced through the clot 2000 can contain and/orconstrain the thrombus extraction device 202. In some embodiments,distally advancing the portion of the thrombus extraction catheter 104through the clot can include advancing the portion of the thrombusextraction catheter 104 until the radiopaque marker 222, that can befluoroscopically monitored and that can be located at the distal end 218of the inner shaft 200, is distally past the thrombus 2200 and/or aportion of the thrombus 2200.

After the portion of the thrombus extraction catheter 104 is distallyadvanced through the clot 2200, the thrombus extraction device 202 canbe deployed as depicted in FIG. 23-G. In some embodiments, the thrombusextraction device 202 can be deployed by either advancing the thrombusextraction device 202 beyond the distal end 204 of the outer shaft 138or by retracting the outer shaft 138 relative to the thrombus extractiondevice 202 until the thrombus extraction device 202 is beyond the distalend 204 of the outer shaft 138. In some embodiments, the thrombusextraction device can be deployed such that the thrombus extractiondevice 202 is distally past the thrombus 2200 and/or distally past adesired portion of the thrombus 2200.

In some embodiments, the thrombus extraction device is advanced beyondthe distal end 204 of the outer shaft 138 by distally advancing theintermediate shaft 140 with respect to the outer shaft 138. In someembodiments, the intermediate shaft 140 can be distally advanced untilthe lock feature 146 contacts the mating feature 148, and the lockfeature 146 can be mated and/or secured to the mating feature 148 to fixthe relative position of the intermediate shaft 140 with respect to theouter shaft 138.

In some embodiments, the deployment of the thrombus extraction device202 can be monitored, and specifically, the deployment of the thrombusextraction device 202 can be fluoroscopically monitored via, forexample, the radiopaque marker 222 and the radiopaque marker located atone or both of the distal end 204 of the outer sheath 138 and the distalend 212 of the intermediate sheath 140. In some embodiments, thedeployment of the thrombus extraction device 202, and specifically theadvancing of the thrombus extraction device 202 beyond the distal end204 of the outer shaft 138 or retracting the outer shaft 138 relative tothe thrombus extraction device 202 can be ceased based on a position thedistal end 204 of the outer sheath 138 comprising the radiopaque marker(first radiopaque marker) relative to the radiopaque marker 222 locatedon the thrombus extraction device 202 (second radiopaque marker).

After the thrombus extraction device 202 is deployed, the thrombusextraction device 202 can be fully expanded as shown in FIG. 23-H. Insome embodiments, this can include allowing the full expansion of thethrombus extraction device 202 such that the thrombus extraction device202 engages a wall 2220 of the blood vessel 2202. In some embodiments,the thrombus extraction device 202 can be fully expanded by moving theplunger 154 from the first position to the second position and securingthe plunger 154 in the second position to thereby fix the relativeposition of the inner shaft 200 with respect to the intermediate shaft140. In some embodiments, the movement of the plunger 154 from the firstposition to the second position proximally retracts the inner shaft 200with respect to the intermediate shaft 140 to thereby fully expand theexpandable cylindrical portion 208 of the thrombus extraction device202. The proximal retraction of the inner shaft 200 with respect to theintermediate shaft 140 can further bring the stop 702 into engagementwith the ring feature 700 to thereby fully expand the self-expandingcoring element 206. In some embodiments, the securing of the plunger 154in the second position can secure the self-expanding coring element 206and the thrombus extraction device 202 in full expansion via theengagement of the stop 702 with the ring feature 700.

With reference now to FIGS. 24-A and 24-B, alternative embodiments ofthe steps shown in FIGS. 23-G and 23-H are shown. In some embodiments,these alternative embodiments can be performed when the diameter of theblood vessel 2202 containing the thrombus 2200 decreases below a desiredlevel distally beyond the thrombus 2200. In some embodiments, forexample, as the distance from the heart increases, the diameter of theblood vessel 2202 can decrease. In some embodiments, this diameter candecrease to a point that use of the thrombus extraction device 202 mayno longer be possible.

In such an embodiment, an extension sheath 2300, also referred to hereinas a popliteal sheath 2300, can be percutaneously inserted into theblood vessel 2202 through the wall 2220 of the blood vessel 2202 suchthat at least a portion of the extension sheath 2300 extends from thepatient. In some embodiments, the extension sheath 2300 can bepercutaneously inserted into the blood vessel 2202 at a position beforethe blood vessel diameter decreases below a desired value such as, forexample, below 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 8 mm, 10 mm, or anyother or intermediate value. In some embodiments the extension sheath2300 can be inserted into the blood vessel 2202 via an access site suchas, for example, the popliteal access site or other venous or arterialaccess sites.

The thrombus extraction device 202 can be deployed as depicted in FIG.24-A. In some embodiments, the thrombus extraction device 202 can bedeployed by either advancing the thrombus extraction device 202 beyondthe distal end 204 of the outer shaft 138 and into the extension sheath2300 or by advancing the outer shaft 138 containing the thrombusextraction device 202 into the extension sheath and then retracting theouter shaft 138 relative to the thrombus extraction device 202 until thethrombus extraction device 202 is beyond the distal end 204 of the outershaft 138. In some embodiments, the thrombus extraction device can bedeployed such that the thrombus extraction device 202 is distally pastthe thrombus 2200 and/or distally past a desired portion of the thrombus2200. In some embodiments, all or portions of the thrombus extractiondevice can be contained within the extension sheath 2300.

In some embodiments, the outer shaft 138 of the thrombus extractioncatheter 104 can be separable into a first piece and a second piece. Insome embodiments, this separation can occur at a separation point thatcan comprise, for example, any feature configured to allow separation ofthe first and second pieces. These features can include a partial depthslit or score in the outer shaft 138, an overlapping friction fit in theouter shaft 138, or the like. In some embodiments, the separable outershaft 138 can be used in the place of the extension sheath 2300. In suchan embodiment, the outer shaft 138 can exit the blood vessel 2202 viathe access site such that the separable portion extends from inside theblood vessel 2202 to outside of the patient's body at the access point.In such an embodiment, the separation portion of the outer sheath 138can serve as the extension sheath 2300 and can remain in the accesspoint when the thrombus extraction device 202 is retracted. Thus, thethrombus extraction device 202 can be deployed by securing the positionof the separation portion of the outer sheath 138 and retracting thethrombus extraction device 202 from that separation portion of the outersheath 138.

In some embodiments, the thrombus extraction device can be advancedbeyond the distal end 204 of the outer shaft 138 by distally advancingthe intermediate shaft 140 with respect to the outer shaft 138. In someembodiments, the intermediate shaft 140 can be distally advanced untilthe lock feature 146 contacts the mating feature 148. In someembodiments, the lock feature 146 can be mated and/or secured to themating feature 148 to fix the relative position of the intermediateshaft 140 with respect to the outer shaft 138.

In some embodiments, the deployment of the thrombus extraction device202 can be fluoroscopically monitored, and specifically, the deploymentof the thrombus extraction device 202 can be fluoroscopically monitoredvia, for example, the radiopaque marker 222 and the radiopaque markerlocated at one or both of the distal end 204 of the outer sheath 138 andthe distal end 212 of the intermediate sheath 140. In some embodiments,the deployment of the thrombus extraction device 202, and specificallythe advancing of the thrombus extraction device 202 beyond the distalend 204 of the outer shaft 138 or retracting the outer shaft 138relative to the thrombus extraction device 202 can be seized based on aposition the distal end 204 of the outer sheath 138 comprising theradiopaque marker (first radiopaque marker) relative to the radiopaquemarker 222 located on the thrombus extraction device 202 (secondradiopaque marker).

After the thrombus extraction device 202 is deployed, the thrombusextraction device 202 can be fully expanded as shown in FIG. 24-B. insome embodiments, the thrombus extraction device 202 can be fullyexpanded while all or portions of the thrombus extraction device 202 arecontained in the extension sheath 2300. In such an embodiment, theportions of the thrombus extraction device 202 contained in theextension sheath 2300 can be prevented from reaching full expansion bythe extension sheath 2300. In such an embodiment, the thrombusextraction device 202 can reach full expansion as the thrombusextraction device is proximately retrieved from the extension sheath2300.

In some embodiments, the full expansion of the thrombus extractiondevice 202 can include allowing the expansion of the thrombus extractiondevice 202 such that the thrombus extraction device 202 engages a wall2220 of the blood vessel 2202. In some embodiments, the thrombusextraction device 202 can be fully expanded by moving the plunger 154from the first position to the second position and securing the plunger154 in the second position to thereby fix the relative position of theinner shaft 200 with respect to the intermediate shaft 140. The movementof the plunger 154 from the first position to the second position canproximally retract the inner shaft 200 with respect to the intermediateshaft 140 to thereby expand the expandable cylindrical portion 208 ofthe thrombus extraction device 202. In some embodiments, the proximalretraction of the inner shaft 200 with respect to the intermediate shaft140 can further bring the stop 702 into engagement with the ring feature700 to thereby fully expand the self-expanding coring element 206. Insome embodiments, the securing of the plunger 154 in the second positioncan secure the self-expanding coring element 206 and the thrombusextraction device 202 in full expansion via the engagement of the stop702 with the ring feature 700

In some such embodiments in which the TED 202 is all or wholly containedwithin the extension sheath 2300, the TED 202 can be retracted until theself-expanding coring element 206 is outside of the extension sheath2300, and which point the inner shaft 200 can be decoupled from thedistal end 217 of the expandable cylindrical portion 208 and the plunger154 can be moved from the first position to the second position to bringthe self-expanding coring element 206 to full expansion. The TED 202 canthen be further retracted and the expandable cylindrical portion 208 canbe expanded by progressively recoupling the distal end 217 of theexpandable cylindrical portion 208 with the inner shaft 200 as theexpandable cylindrical portion 208 exits the extension sheath 2300 untilthe expandable cylindrical portion 208 has completely exited theextension sheath 2300 and is at full expansion with the distal end 217of the expandable cylindrical portion 208 recoupled to the inner shaft140. Alternatively, in some embodiments, the distal end 217 of theexpandable cylindrical portion 208 can remain uncoupled to the innershaft 140 until the expandable cylindrical portion 208 has completelyexited the extension sheath 2300. Once the expandable cylindricalportion 208 has completely exited the extension sheath 2300, the distalend 217 of the expandable cylindrical portion 208 can be recoupled tothe inner shaft 200 and the expandable cylindrical portion 208 can beexpanded to full expansion.

With reference now to FIGS. 25-A to 25-H a process for removal ofthrombus 2200 with an expanded thrombus extraction device 202 is shown.In some embodiments, the thrombus 2200 can be removed via the capture ofthe thrombus in the thrombus extraction device 202 via the proximalretraction of the thrombus extraction device 202 through the thrombus2200, which proximal retraction of the thrombus extraction device 202can be, for example, in a direction of blood flow through the bloodvessel 2202 or against the direction of blood flow through the vessel2202. In some embodiments, the proximal retraction of the thrombusextraction device 202 through the thrombus 2200 can result in thecapture of the distal end 2206 of the thrombus 2200 before the captureof the proximal end 2204 of the thrombus 2200.

In some embodiments, the proximal retraction of the thrombus extractiondevice 202 can result in the separation and/or coring of at least aportion of the thrombus 2200 from the wall 2220 of the blood vessel 2202by, for example, the self-expanding coring element 206 and/or the stentportion, and the capture of that separated portion of the thrombus 2200within the expandable cylindrical portion 208. In some embodiments, theexpandable cylindrical portion 208 can be formed of the braided filamentmesh structure that can be, for example, a net-like filament meshstructure. In some embodiments, a portion of the thrombus can becaptured within the expandable cylindrical portion 208 by entering theexpandable cylindrical portion 208 via the mouth 414 of theself-expanding coring element 206 and/or via one or several of theinterstices 404 of the self-expanding coring element 206.

As seen in FIG. 25-A, the distal end 2206 of the thrombus 2200 isseparated and/or cored from the walls 2220 of the blood vessel 2202 bythe self-expanding coring element 206 via the proximal retraction of thethrombus extraction device 202. As seen in FIG. 25-B, the distal end2206 of the thrombus 2200 is captured in the expandable cylindricalportion 208 of the thrombus extraction device by the continued proximalretraction of the thrombus extraction device through the thrombus 2200.The separation and capture and/or coring and capture of further portionsof the thrombus 2200 by the continued proximal retraction of thethrombus extraction device 202 is shown in FIGS. 25-C, 25-D, and 25-E.As seen in FIG. 25-E, the proximal end 2204 of the thrombus 2200 iscored and captured as the thrombus extraction device 202 is proximallyretracted towards the self-expanding funnel 1708.

In some embodiments, the thrombus extraction device 202 can beproximally retracted until a portion of the self-expanding coringelement 206 is contained within the self-expanding funnel 1708 as seenin FIG. 25-F, and specifically until the mouth 414 of the self-expandingcoring element 206 is contained within the self-expanding funnel 1708.In some embodiments, the containment of the mouth 414 within theself-expanding funnel 1708 can be fluoroscopically verified. In someembodiments, the mouth 414 can be determined as wholly contained withinthe self-expanding funnel 1708 via fluoroscopic monitoring based on thealignment/relative positioning of the distal end 212 of the intermediateshaft 140 comprising a radiopaque marker 2450 and/or the radiopaquemarker 222 with respect to the distal end 110 comprising a radiopaquemarker 2452 of the elongate member 106 of the introducer sheath 102.

When the portion of the self-expanding coring element 206 is containedwithin the self-expanding funnel 1708, or specifically when the mouth414 of the self-expanding coring element 206 is wholly contained withinthe self-expanding funnel 1708, the plunger 154 can be unlocked from thesecond position and can be moved from the second position to the firstposition to thereby move the thrombus extraction device 202 from andexpanded configuration to an unexpanded configuration. In someembodiments, the unlocking of the plunger 154 from the second positioncan unlock and/or decouple the inner shaft 200 with respect to theintermediate shaft 140, and the moving of the plunger 154 from thesecond position to the first position can cause the distal advancing ofthe inner shaft 200 relative to the intermediate shaft 140.

In some embodiments, the thrombus extraction device 202 can be collapsedby moving the thrombus extraction device 202 from the expandedconfiguration to the unexpanded configuration prior to withdrawing thethrombus extraction device 202 from the patient's body so as to compressthe thrombus 2200 captured by the thrombus extraction device 202. Insome embodiments, the compression of the thrombus 2200 by the thrombusextraction device 202 can secure the position of the thrombus within thethrombus extraction device 202 via, in some embodiments, the engagementof one or several of the plurality of circumferential depressions 1000with the thrombus 2200.

After the thrombus extraction device 202 has been collapsed, thethrombus extraction device 202 can be proximally retracted through theself-expanding funnel 1708 and into the elongate member 106 as depictedin FIG. 25-G. In some embodiments, the collapse of the thrombusextraction device 202 and/or the retraction of the thrombus extractiondevice 202 into the self-expanding funnel 1708 and/or the elongatemember can result in the extrusion of all or portions of the thrombus2200 through pores of the expandable cylindrical portion 208 of thethrombus extraction device 202 including, for example, some or all ofthe first plurality of pores 904 and/or the second plurality of pores906. In some embodiments, the all or portions of the thrombus 2200 canbe extruded through some or all of the second plurality of pores 906which can be larger than the first plurality of pores 904. In someembodiments, the pores in the second plurality of pores 906 can be sizedto be sufficiently small such that any thrombus portions of the thrombus2200 extruded through the pores is sufficiently small to have little orno clinical significance. In some embodiments, these extruded all orportions of the thrombus 2200 can be captured by the self-expandingfunnel 1708.

The thrombus extraction device 202 can continue to be proximallyretracted as depicted in FIG. 25-H until the thrombus extraction device202 and the captured thrombus 2200 is fully contained within theelongate member 106. In some embodiments, the seal dilator 170 can beinserted into the sealed aperture 112 and the thrombus extraction device202 and the captured thrombus 2200 can then be withdrawn or removed fromthe patient's body and from the elongate member 106 via the sealedaperture 112 in the seal dilator 170. In some embodiments, thrombuscaptured by the self-expanding funnel 1708 can then either be guidedinto the elongate member 106 and specifically into the lumen 1701 of theelongate member 106 or further compressed and/or broken up by theself-expanding funnel 1708 and then allowed to pass through theself-expanding funnel 1708, and particularly through the mesh of theself-expanding funnel 1708. In some embodiments, this thrombus can beaspirated through the lumen 1701 of the elongate member 106 and theaspiration port 114. In some embodiments, the aspiration of the thrombusvia the aspiration port 114 can include the opening of the aspirationvalve 118. After the thrombus is captured by the self-expanding funnel1708 has been aspirated, the introducer sheath 102 can be removed fromthe patient's body.

With reference now to FIGS. 26-28, introduction techniques for accessingthe thrombus 2200 are shown. In some embodiments, these introductiontechniques can allow the use of a larger sized introducer sheath 102 dueto the larger size of the vessels in the path to the thrombus. In someembodiments, this larger size of the introducer sheath 102 can ease theremoval of thrombus through the introducer sheath 102 as, in someembodiments, the size of the lumen 1701 of the introducer sheath 102 canincrease as the size of the introducer sheath 102 increases. Further, insome embodiments, the user of a larger sized introducer sheath 102 canallow the removal of larger thrombus. In some embodiments, the lengthsof the components of the thrombus extraction system 100, andparticularly the lengths of the introducer sheath 102 and the thrombusextraction catheter 104 can vary based on the selected technique foraccessing the thrombus and/or based on the location of the thrombus.

As seen in FIG. 26, the introducer sheath 102 can be inserted into thepatient's body via an internal jugular access site 2500. The introducersheath 102 can extend from the internal jugular access site 2500 to thedeployment position 2502 which can be proximal to the thrombus 2200. Inembodiments in which the introducer sheath 102 comprises theself-expanding funnel 1708, the self-expanding funnel 1708 can bedeployed at the deployment position 2502. In the embodiment shown inFIG. 26, the introducer sheath can extend from the internal jugularaccess site 2500 through the superior vena cava and the inferior venacava to the deployment position 2502 in one of the common iliac veins.In some embodiments, the deployment position 2502 can be located in, forexample, the inferior vena cava, one of the iliac veins, the femoralvein, the popliteal vein, before or beyond the iliac arch, or any otherlocation proximate to and/or proximal to the thrombus 2200. In someembodiments, the use of the internal jugular access site 2500 can allowfor a larger diameter of the elongate member 106.

As seen in FIG. 27, in some embodiments, use of the internal jugularaccess site 2500 can be combined with use of the extension sheath 2300that can be inserted into the blood vessel 2202 at a popliteal accesssite 2600. In some such embodiments, the thrombus extraction device canwholly or partially exit the patient's body while contained in theextension sheath 2300 before being retracted through the thrombus 2200.

As seen in FIG. 28, the introducer sheath can, in some embodiments, beinserted into the patient's body into an access site connected to theblood vessel 2202 containing the thrombus via the common iliac veins. Inthe specific embodiment shown in FIG. 28, this can be achieved viainsertion into the patient's body via a femoral access site 2700. Insome embodiments, use of an access site connected to the blood vessel2202 via the common iliac veins, and specifically user of the femoralaccess site 2700 can be combined with user of the extension sheath 2300that can be inserted into the blood vessel 2202 at a popliteal accesssite 2600. In some such embodiments, the thrombus extraction device canwholly or partially exit the patient's body while contained in theextension sheath 2300 before being retracted through the thrombus 2200.

With reference now To FIG. 29, a side view of another embodiment of thethrombus extraction device 202 is shown. The TED 202 shown in FIG. 29can be used with other components of the thrombectomy system 100 shownand discussed above. The thrombus extraction device 202 can include theself-expanding coring element 206, and the expandable cylindricalportion 208 that can be the braided filament mesh structure 704. Theself-expanding coring element 206, which can include the mouth 414, alsoreferred to herein as the opening 414, can be relatively more proximallylocated on the thrombus extraction catheter 104 than the expandablecylindrical portion 208. The self-expanding coring element 206 caninclude a proximal end 210 connecting to a distal end 212 of theintermediate shaft 140 and a distal end 214 connecting to a proximal end216 of the expandable cylindrical portion 208.

The distal end 217 of the expandable cylindrical portion 208 can connectto one of: the second intermediate shaft 3000, the third intermediateshaft 3002; and the inner shaft 200. In some embodiments, thisconnection can be to a distal end 218 of the one of: the secondintermediate shaft 3000, the third intermediate shaft 3002; and theinner shaft 200, and in some embodiments, this connection can be at alocation intermediate between the proximal end and the distal end 218 ofthe one of: the second intermediate shaft 3000, the third intermediateshaft 3002; and the inner shaft 200. In some embodiments, thisconnection can be a fixed connection and in some embodiments, thisconnection can be a slidable connection.

The expandable cylindrical portion 208 can include an everted portion2900 and a non-everted portion 2902. In some embodiments, thenon-everted portion can be proximate to the proximal end 216 of theexpandable cylindrical portion 208 and can connect to the self-expandingcoring element 206. The everted portion 2900 can, in some embodiments,extend proximally through the non-everted portion 2902 and/or throughthe self-expanding coring element 206, and particularly through themouth 414 of the self-expanding coring element 206. The distal end 217of the expandable cylindrical portion 208 can be moveable with respectto the self-expanding coring element 206 such that the relative sizeand/or length of the everted portion 2900 changes with respect to thesize and/or length of the non-everted portion 2902. In embodiments inwhich the distal end 217 of the expandable cylindrical portion 208 isfixed to one of: the second intermediate shaft 3000, the thirdintermediate shaft 3002; and the inner shaft 200, the length of theeverted portion 2900 relative to the non-everted portion 2902 variesbased on the position of the first intermediate shaft 140 relative tothe position of the one of: the second intermediate shaft 3000, thethird intermediate shaft 3002; and the inner shaft 200 to which theself-expanding coring element 206 is connected.

The distal end 218 of the inner shaft 200 can further include a tip 220such as an atraumatic tip and/or a radiopaque marker 222. In someembodiments, the tip 220 can include the radiopaque marker 222. Furtherradiopaque markers can be located on, for example, the outer shaft 138and specifically the distal end 204 of the outer shaft 138 and/or thedistal end 212 of the intermediate shaft 140. In some embodiments, oneor both of the distal end 204 of the outer shaft 138 and the distal end212 of the intermediate shaft 140 can each comprise a radiopaque marker.In some embodiments, the atraumatic tip 220 can define a channelconfigured to allow the guidewire to pass through the atraumatic tip220.

With reference now to FIGS. 30 and 31, side, section views of otherembodiments of the thrombus extraction device 202 and portions of thethrombus extraction catheter 104 are shown. Specifically, FIG. 30depicts an embodiment of the thrombus extraction device 202 in which theexpandable cylindrical portion 208 everts on itself. As depicted, theeverted portion 2900 of the expandable cylindrical portion 208 iseverted such that the everted portion 2900 of the expandable cylindricalportion 208 extends through the non-everted portion 2902 and through theself-expanding coring element 206, and specifically, the everted portion2900 is everted such that the everted portion 2900 extends proximallythrough the non-everted portion 2902 and proximally through theself-expanding coring element 206.

In FIG. 30, the thrombus extraction device 202 includes theself-expanding coring element 206, and the expandable cylindricalportion 208. The self-expanding coring element 206 includes the mouth414. Further, the distal end 217 of the expandable cylindrical portion208 connects to a distal end 3004 of the third intermediate shaft 3002that coaxially extends through a lumen of the second intermediate shaft3000, which likewise coaxially extends through the first intermediateshaft 140. As further seen, the thrombus extraction device 202 includesthe inner shaft 200 including the atraumatic tip 220. In one embodimentthe inner shaft 200 is not coupled with the expandable cylindricalportion 208, but rather is independently movable with respect to theexpandable cylindrical portion 208. In another embodiment, the innershaft 200 is fixed to the proximal end of the expandable cylindricalportion 208 and can be manipulated to purposefully expand or retract thecylindrical portion 208.

The second intermediate shaft 3000 includes a stop 702 that, with thering 700 of the self-expanding coring element 206, is part of theexpansion mechanism 701. In some embodiments, this stop 702 can be atab, a protrusion, a flange, a ridge or the like. The expansionmechanism 701 can, with components discussed above with respect to FIGS.12-14, be configured to maintain a desired radial force on a vessel wallwith the unitary fenestrated structure and/or to hold the thrombusextraction device 202 and/or the self-expanding coring element 206 atfull expansion and/or in full expansion.

In some embodiments, the stop 702 can directly engage with the ring 700and in some embodiments, the stop 702 can be coupled with the ring 700via, for example, a force transfer features such as spring which can bea compression spring or a tension spring. In some embodiments, forexample, the stop 702 can be proximally located with respect to the ring700 can the stop and the ring can be coupled by a tension spring suchthat a force is applied to the ring 700 via the spring when the stop 702is in position for full expansion.

In some embodiments, the expandable cylindrical portion 208 can becoupled and/or connected to a distal end 218 of the one of: the secondintermediate shaft 3000, the third intermediate shaft 3002; and theinner shaft 200, and in some embodiments, the expandable cylindricalportion 208 can be coupled and/or connected to a distal end 218 of theone of: the second intermediate shaft 3000, the third intermediate shaft3002; and the inner shaft 200 at a location intermediate between theproximal end and the distal end 218 of the one of: the secondintermediate shaft 3000, the third intermediate shaft 3002; and theinner shaft 200. In some embodiments, this connection can be a fixedconnection and in some embodiments, this connection can be a slidableconnection.

The expandable cylindrical portion 208 can include an everted portion2900 and a non-everted portion 2902. In some embodiments, thenon-everted portion 2902 can be proximate to the proximal end 216 of theexpandable cylindrical portion 208 and can connect to the self-expandingcoring element 206. The everted portion 2900 can, in some embodiments,extend proximally through the non-everted portion 2902 and/or throughthe self-expanding coring element 206, and particularly through themouth 414 of the self-expanding coring element 206. The distal end 217of the expandable cylindrical portion 208 can be moveable with respectto the self-expanding coring element 206 such that the relative sizeand/or length of the everted portion 2900 changes with respect to thesize and/or length of the non-everted portion 2902. In embodiments inwhich the distal end 217 of the expandable cylindrical portion 208 isfixed to one of: the second intermediate shaft 3000, the thirdintermediate shaft 3002; and the inner shaft 200, the length of theeverted portion 2900 relative to the non-everted portion 2902 variesbased on the position of the first intermediate shaft 140 relative tothe position of the one of: the second intermediate shaft 3000, thethird intermediate shaft 3002; and the inner shaft 200 to which theself-expanding coring element 206 is connected.

The distal end 218 of the inner shaft 200 can further include a tip 220such as an atraumatic tip and/or a radiopaque marker 222. In someembodiments, the tip 220 can include the radiopaque marker 222. Furtherradiopaque markers can be located on, for example, the outer shaft 138and specifically the distal end 204 of the outer shaft 138 and/or thedistal end 212 of the intermediate shaft 140. In some embodiments, oneor both of the distal end 204 of the outer shaft 138 and the distal end212 of the intermediate shaft 140 can each comprise a radiopaque marker.In some embodiments, the atraumatic tip 220 can define a channelconfigured to allow the guidewire to pass through the atraumatic tip220.

In some embodiments, the thrombus extraction catheter 104 can include aneversion stop 3006. The eversion stop 3006 can include one or severalfeatures that limit the proximal displacement of the distal end 217 ofthe expandable cylindrical portion 208 to prevent over-eversion of theTED 202. In some embodiments, the eversion stop 3006 can be configuredto limit proximal movement of the one of: the second intermediate shaft3000, the third intermediate shaft 3002; and the inner shaft 200 towhich the distal end 217 of the expandable cylindrical portion 208 iscoupled. In some embodiments, this can prevent full eversion of theexpandable cylindrical portion 208.

The eversion stop 3006 can increase the effectiveness of the thrombusextraction device 202. In some embodiments, for example, the eversion ofthe expandable cylindrical portion 208 on the self-expanding coringelement 206 can result in the inability to distally advance the distalend 217 of the expandable cylindrical portion 208 to fully deploy theexpandable cylindrical portion 208.

FIG. 31 depicts and embodiment of the thrombus extraction device 202 inwhich the expandable cylindrical portion 208 everts on theself-expanding coring element 206. As depicted in FIG. 31, the evertedportion 2900 of the expandable cylindrical portion 208 connects directlyto the distal end 214 of the self-expanding coring element 206 and iseverted such that the everted portion 2900 of the expandable cylindricalportion 208 extends through the self-expanding coring element 206, andspecifically, the everted portion 2900 is everted such that the evertedportion 2900 extends proximally through the self-expanding coringelement 206. As further seen, the thrombus extraction device 202includes the inner shaft 200 including the atraumatic tip 220. The innershaft 200 is coupled with the expandable cylindrical portion 208 via acoupling 3100, which coupling 3100 can fixedly couple the distal end 217of the expandable cylindrical portion 208 to the inner shaft 200 and/orwhich coupling 3100 can slidably couple the distal end 217 of theexpandable cylindrical portion 208 to the inner shaft 200. In someembodiments, the distal end 217 of the expandable cylindrical portion208 can be similarly coupled to either the second intermediate shaft3000 or the third intermediate shaft 3002. In some embodiments in whichthe coupling 3100 fixedly couples the distal end 217 of the expandablecylindrical portion 208 to the inner shaft 200, the relative length ofthe everted portion 2900 and the non-everted portion 2902 can be changedvia the relative displacement of the inner shaft 200 with respect to thefirst intermediate shaft 140. In embodiments in which the coupling 3100slidably couples the distal end 217 of the expandable cylindricalportion 208 to the inner shaft 200, the relative length of the evertedportion 2900 and the non-everted portion 2902 can be changed via theapplication of a force to the expandable cylindrical portion 208 suchas, for example, the force applied to the expandable cylindrical portion208 by the portion of the thrombus when the thrombus extraction device202 is retracted through the thrombus.

Although the embodiment of FIG. 31 depicts the expandable cylindricalportion 208 connected to the inner shaft 200, the expandable cylindricalportion 208 can be coupled and/or connected to a distal end 218 of theone of: the second intermediate shaft 3000, the third intermediate shaft3002; and the inner shaft 200, and in some embodiments, the expandablecylindrical portion 208 can be coupled and/or connected to a distal end218 of the one of: the second intermediate shaft 3000, the thirdintermediate shaft 3002; and the inner shaft 200 at a locationintermediate between the proximal end and the distal end 218 of the oneof: the second intermediate shaft 3000, the third intermediate shaft3002; and the inner shaft 200.

With reference now to FIGS. 32 and 33, an embodiment of the TED 202 isshown in which the relative sizes and/or lengths of the everted portion2900 and the non-everted portion 2902 differ. Thus, relative length ofthe everted portion 2900 with respect to the non-everted portion 2902 isgreater in FIG. 32 than in FIG. 33. As depicted in FIGS. 32 and 33, therelative length and/or size of the everted portion 2900 with respect tothe non-everted portion 2902 is changed via the relative position of theinner shaft 200 with respect to the first intermediate shaft 140 as theinner shaft 200 is distally advanced with respect to the firstintermediate shaft 140 in FIG. 33 as compared to FIG. 32 such that theinner shaft 200 distally extends from the first intermediate shaft 140in FIG. 33.

As further seen in FIG. 33, the length of the everted portion 2900extends from the most distal inflection point between the evertedportion 2900 and the non-everted portion 2902 until the most distal end217 of the expandable cylindrical portion 208, which can include, forexample, the coupling 3100. In the embodiment of FIG. 32, while thedistal end 217 is within the first intermediate shaft 140, and thus notvisible, the everted portion 2900 nevertheless extends to this distalend 217 of the expandable cylindrical portion 208. As further seen theeverted portion 2900 extends from the most distal inflection pointbetween the everted portion 2900 and the non-everted portion 2902 untilthe proximal end 216 of the expandable cylindrical portion 208.

With reference now to FIGS. 34-A to 34-D views depicting one embodimentof a process for affecting the relative lengths of the everted portion2900 and the non-everted portion 2902 of a thrombus extraction device ina blood vessel 2202 are shown. In some embodiments, the process of FIGS.34-A to 34-D can be performed as a part of, or in the place of theprocess shown in FIGS. 23-A to 23-H, and particularly in the place ofsteps 23-G and 23-H. In some embodiments, the process of FIGS. 34-A to34-D can be performed as a part of or in the place of the process ofFIGS. 24-A and 24-B, or of FIGS. 25-A to 25-H. In some embodiments, forexample, the process of FIGS. 34-A to 34-D can advantageously eliminatethe necessity of performing the process of FIGS. 24-A and 24-B as theexpandable cylindrical portion 208 of the thrombus extraction device 202can be controlled to limit the extension of the thrombus extractiondevice 202 beyond the thrombus 2200. This benefit of the process ofFIGS. 34-A to 34-D is particularly advantageous when the thrombus 2200forms proximate to a feature 3400 such as the valve 3400.

The process for affecting the relative lengths of the everted portion2900 and the non-everted portion 2902 in a blood vessel 2202 can beperformed using all or portions of the thrombus extraction system 100.In some embodiments, the process for affecting the relative lengths ofthe everted portion 2900 and the non-everted portion 2902 in a bloodvessel 2202 can be performed in connection with a monitoring technique,such as fluoroscopy, angiography, and/or ultrasonic monitoring. In someembodiments, the monitoring technique can be used to monitor thedeployment of the thrombus extraction device 202 in the vessel viaobservation of the one or several radiopaque markers located on theintroducer sheath 102 and/or the thrombus extraction catheter 104.

The process begins at FIG. 34-A, wherein the thrombus 2200 is identifiedin the blood vessel 2202 such as venous vessel. In some embodiments, thethrombus 2200 can be located in the peripheral vasculature of thepatient's body. The thrombus 2200 can comprise the proximal end 2204 andthe distal end 2206. In some embodiments, the identification of theblood vessel 2202 can further include the determination of whether thethrombus 2200 in the blood vessel 2202 is suitable for thrombusextraction. In some embodiments, the thrombus 2200 in the blood vessel2202 can be suitable for extraction when the blood vessel 2202 has adiameter of at least 3 millimeters. In some embodiments, the thrombus2200 in the blood vessel 2202 can be suitable for extraction when theblood vessel 2202 has a diameter of at least 3 millimeters and is atleast one of a femoral vein, an iliac vein, a popliteal vein, aposterior tibial vein, an anterior tibial vein, or a peroneal vein. Insome embodiments, and as part of identifying the thrombus 2200, afeature 3400 can be identified, which feature 3400 can be located distalof the distal end 2206 of the thrombus 2200.

After the thrombus 2200 has been identified, a guidewire 3402 can beinserted through the blood vessel 2202, through the thrombus 2200, andin some embodiments, through the feature 3400. In some embodiments, theguidewire 3402 can be inserted into the blood vessel via an access sitesuch as, for example, the internal jugular (IJ) access site, the femoralaccess site, the popliteal access site, or other venous or arterialaccess sites. In some embodiments, the guidewire 3402 can be insertedusing one or several imaging and/or monitoring techniques including, forexample, fluoroscopy, angiography, and/or ultrasonic monitoring.

After the thrombus 2200 has been identified, a portion of the thrombusextraction catheter 104 such as the outer shaft 138 can be inserted intothe blood vessel 2202 as shown in FIG. 34-B. In some embodiments, thethrombus extraction catheter 104 including the thrombus extractiondevice can be inserted into the blood vessel via an access site such as,for example, the internal jugular (IJ) access site, the femoral accesssite, the popliteal access site, or other venous or arterial accesssites. In some embodiments, the thrombus extraction catheter 104including the thrombus extraction device can be inserted into thepopliteal access site and distally advanced, towards the feet of thepatient. In some embodiments, the thrombus extraction device containedwithin the thrombus extraction catheter 104 can include the evertedportion and the non-everted portion.

In some embodiments, the insertion of the thrombus extraction catheter104 such as the outer shaft 138 can be inserted into the blood vessel2202 can include performing the steps discussed above with respect toFIGS. 23-B to 23-D. In some embodiments, inserting a portion of thethrombus extraction catheter 104 into the blood vessel 2202 can includeproviding the thrombus extraction catheter 104 which comprises thethrombus extraction device 202. In some embodiments, the thrombusextraction device 202 can be constrained within the outer shaft 138 andcan inserted, together with the outer shaft 138, into the blood vessel2202 via, for example insertion into lumen of the elongate member 106via the sealed aperture 112. In some such embodiments, the outer shaft138 of the thrombus extraction catheter 104 can have a diameter so as todilate the seal of the sealed aperture 112 such that the sealed aperture112 seals around and seals to the outer shaft 138.

After the portion of the thrombus extraction catheter 104 has beeninserted into the blood vessel 2202, a portion of the thrombusextraction catheter 104 can be distally advanced through the clot 2200as depicted in FIG. 34-B. In some embodiments, this distal advancethrough the clot 2200 can be either with or against the direction ofblood flow. In some embodiments, the portion of the thrombus extractioncatheter 104 distally advanced through the clot 2000 can contain and/orconstrain the thrombus extraction device 202. In some embodiments,distally advancing the portion of the thrombus extraction catheter 104through the clot can include advancing the portion of the thrombusextraction catheter 104 until the tip 220 reaches a desired locationproximate and/or proximal to the feature 3400. In some embodiments,distally advancing the portion of the thrombus extraction catheter 104through the clot can include advancing the portion of the thrombusextraction catheter 104 until the tip 220 reaches a desired locationdistal to the feature 3400.

In some embodiments, this desired location can be intermediate betweenwith the feature 3400 and the distal end 2206 of the thrombus 2200. Insome embodiments, the desired location can be sufficiently distal fromthe distal end 2206 of the thrombus to allow the deployment of thethrombus extraction device 202, and particularly of the self-expandingcoring element 206 between the distal end 2206 of the thrombus 2200 andthe feature 3400. In some embodiments, the desired location can besufficiently distal from the distal end 2206 of the thrombus to allowthe deployment of the thrombus extraction device 202, and particularlyof the self-expanding coring element 206 between the distal end 2206 ofthe thrombus 2200 and the feature 3400 without having all or a portionof the tip 220 or all or a portion of the thrombus extraction device 202extend through the feature 3400. In some embodiments such positioningthat does not extend through the feature 3400 can protect the valve frompotential damage arising from the insertion or retraction of the all ora portion of the tip 220 or all or a portion of the thrombus extractiondevice 202 through the feature 3400.

In some embodiments, the insertion of the portion of the thrombusextraction catheter 104 into the blood vessel 2202 can befluoroscopically monitored based on, for example, one or severalradiopaque markers located in portions of the thrombus extractioncatheter 104 including, for example, the radiopaque marker 222 and theradiopaque marker located at one or both of the distal end 204 of theouter sheath 138 and the distal end 212 of the intermediate sheath 140such as radiopaque marker 2450.

After the portion of the thrombus extraction catheter 104 is distallyadvanced to the desired location, the thrombus extraction device 202 canbe deployed as depicted in FIG. 34-C. In some embodiments, the thrombusextraction device 202 can be deployed by either advancing the thrombusextraction device 202 beyond the distal end 204 of the outer shaft 138or by retracting the outer shaft 138 relative to the thrombus extractiondevice 202 until the thrombus extraction device 202 is beyond the distalend 204 of the outer shaft 138. In some particular embodiments, theposition of the tip 220 can be fixed and/or pinned at the desiredlocation and the thrombus extraction device 202 can be deployed by theproximal retraction of the outer shaft 138 relative to the thrombusextraction device 202 until the self-expanding coring element 206 andany portion of the expandable cylindrical portion 208 extending distallyfrom the self-expanding coring element 206 is beyond the distal end 204of the outer shaft 138. In some embodiments, the thrombus extractiondevice can be deployed such that the self-expanding coring element 206is distally past the thrombus 2200 and/or distally past a desiredportion of the thrombus 2200.

In some embodiments, the thrombus extraction device 202 deployed whenthe lock feature 146 contacts the mating feature 148. In suchembodiments, the lock feature 146 can be mated and/or secured to themating feature 148 to fix the relative position of the intermediateshaft 140 with respect to the outer shaft 138.

In some embodiments, the deployment of the thrombus extraction device202 can be monitored, and specifically, the deployment of the thrombusextraction device 202 can be fluoroscopically monitored via, forexample, the radiopaque marker 222 and the radiopaque marker located atone or both of the distal end 204 of the outer sheath 138 and the distalend 212 of the intermediate sheath 140. In some embodiments, thedeployment of the thrombus extraction device 202, and specifically theadvancing of the thrombus extraction device 202 beyond the distal end204 of the outer shaft 138 or retracting the outer shaft 138 relative tothe thrombus extraction device 202 can be ceased based on a position thedistal end 204 of the outer sheath 138 comprising the radiopaque marker(first radiopaque marker) relative to the radiopaque marker 222 locatedon the thrombus extraction device 202 (second radiopaque marker).

After the thrombus extraction device 202 is deployed, or as a part ofthat deployment, the thrombus extraction device 202 can be fullyexpanded. In some embodiments, this can include allowing the fullexpansion of the self-expanding coring element 206 such that theself-expanding coring element 206 engages a wall 2220 of the bloodvessel 2202. In some embodiments, the thrombus extraction device 202,and specifically the self-expanding coring element 206 can be fullyexpanded by engaging the locking mechanism 701, and in some embodimentsby moving the plunger 154 from the first position to the second positionand securing the plunger 154 in the second position to thereby fix therelative position of the stop 702 with respect to the ring feature 700.In some embodiments, the movement of the plunger 154 from the firstposition to the second position proximally retracts the stop 702 withrespect to the ring feature 700 to thereby fully expand theself-expanding coring element 206 of the thrombus extraction device 202.The proximal retraction of the plunger 154 with respect to theintermediate shaft 140 can further bring the stop 702 into engagementwith the ring feature 700 to thereby fully expand the self-expandingcoring element 206. In some embodiments, the securing of the plunger 154in the second position can secure the self-expanding coring element 206and the thrombus extraction device 202 in full expansion via theengagement of the stop 702 with the ring feature 700.

After the thrombus extraction device 202 is deployed, the thrombusextraction device 202 can be fully expanded as shown in FIG. 23-H. Insome embodiments, this can include allowing the full expansion of thethrombus extraction device 202 such that the thrombus extraction device202 engages a wall 2220 of the blood vessel 2202. In some embodiments,the thrombus extraction device 202 can be fully expanded by moving theplunger 154 from the first position to the second position and securingthe plunger 154 in the second position to thereby fix the relativeposition of the inner shaft 200 with respect to the intermediate shaft140. In some embodiments, the movement of the plunger 154 from the firstposition to the second position proximally retracts the inner shaft 200with respect to the intermediate shaft 140 to thereby fully expand theexpandable cylindrical portion 208 of the thrombus extraction device202. The proximal retraction of the inner shaft 200 with respect to theintermediate shaft 140 can further bring the stop 702 into engagementwith the ring feature 700 to thereby fully expand the self-expandingcoring element 206. In some embodiments, the securing of the plunger 154in the second position can secure the self-expanding coring element 206and the thrombus extraction device 202 in full expansion via theengagement of the stop 702 with the ring feature 700.

After the thrombus extraction device 202 has been deployed, the thrombus2200 can be removed via the capture of the thrombus in the thrombusextraction device 202 via the proximal retraction of the thrombusextraction device 202 through the thrombus 2200 as shown in FIG. 34-D,which proximal retraction of the thrombus extraction device 202 can be,for example, in a direction of blood flow through the blood vessel 2202or against the direction of blood flow through the vessel 2202. In someembodiments, the proximal retraction of the thrombus extraction device202 through the thrombus 2200 can result in the capture of the distalend 2206 of the thrombus 2200 before the capture of the proximal end2204 of the thrombus 2200.

In some embodiments, the proximal retraction of the thrombus extractiondevice 202 can result in the separation and/or coring of at least aportion of the thrombus 2200 from the wall 2220 of the blood vessel 2202by, for example, the self-expanding coring element 206 and/or the stentportion, and the capture of that separated portion of the thrombus 2200within the expandable cylindrical portion 208. In some embodiments, theexpandable cylindrical portion 208 can be formed of the braided filamentmesh structure that can be, for example, a net-like filament meshstructure. In some embodiments, a portion of the thrombus can becaptured within the expandable cylindrical portion 208 by entering theexpandable cylindrical portion 208 via the mouth 414 of theself-expanding coring element 206 and/or via one or several of theinterstices 404 of the self-expanding coring element 206.

The distal end 2206 of the thrombus 2200 is separated and/or cored fromthe walls 2220 of the blood vessel 2202 by the self-expanding coringelement 206 via the proximal retraction of the thrombus extractiondevice 202, and the thrombus 2200 is captured in the expandablecylindrical portion 208 of the thrombus extraction device 202 by thecontinued proximal retraction of the thrombus extraction device throughthe thrombus 2200. In some embodiments, the everted portion 2900 of theexpandable cylindrical portion 208 can be distally advanced relative toand through the self-expanding coring element 206 and/or through thenon-everted portion 2902 of the expandable cylindrical portion 208 inconnection with the proximal retraction of the thrombus extractiondevice 202 to elongate the non-everted portion 2902 to allow capture ofthe thrombus 2200 in the expandable cylindrical portion 208 andparticularly within the non-everted portion 2902 of the expandablecylindrical portion 208. In embodiments in which the distal end 217 ofthe expandable cylindrical portion 208 is slidably coupled to one of:the second intermediate shaft 3000, the third intermediate shaft 3002;and the inner shaft 200, the relative distal advance of the evertedportion 2900 of the expandable cylindrical portion 208 can be achievedvia forces applied to the expandable cylindrical portion 208 as thethrombus extraction device 202 is proximally retracted. In someembodiments, these forces can overcome frictional forces and can thuscause the coupling 3100 to displace distally relative to the one of: thesecond intermediate shaft 3000, the third intermediate shaft 3002; andthe inner shaft 200 with which the coupling 3100 is coupled.

In some embodiments, this distal advance of the everted portion 2900 ofthe expandable cylindrical portion 208 relative to the self-expandingcoring element 206 can be accomplished via the relative distal advanceof the one of: the second intermediate shaft 3000, the thirdintermediate shaft 3002; and the inner shaft 200 with respect to thefirst intermediate shaft 140. In some embodiments in which the distalend 217 of the expandable cylindrical portion 208 is fixedly coupled theone of: the second intermediate shaft 3000, the third intermediate shaft3002; and the inner shaft 200, the relative distal advance can beachieved by the fixing and/or pining of the position of that one of: thesecond intermediate shaft 3000, the third intermediate shaft 3002; andthe inner shaft 200 and the proximal retraction of the firstintermediate shaft 140. In the embodiment of FIG. 34-D in which thedistal end 217 of the expandable cylindrical portion 208 is coupled tothe second intermediate shaft 3000, the position of the secondintermediate shaft 3000 can be pinned relative to the blood vessel 2202,the thrombus 2200 and/or the feature 3400, and the first intermediateshaft 140 can be proximally retracted with respect to the secondintermediate shaft 3000 to increase the length of the non-evertedportion 2902.

In some embodiments, the length of the non-everted portion 2902 of theexpandable cylindrical portion 208 can be increased until the thrombus2202 and/or portion of the thrombus 2202 is entirely captured with thethrombus extraction device 202 and specifically within the expandablecylindrical portion 208, or until the length of the non-everted portion2902 can no longer be increased. In some embodiments, the thrombus 2202can then be removed from the patient's body as depicted in FIGS. 25-Ethrough 25-H.

With reference now to FIG. 35 a schematic illustration of one embodimentof a funnel catheter 3500 is shown. The funnel catheter 3500 can be partof thrombus extraction system 100. The funnel catheter 3500 comprises anelongate funnel member 3502, also referred to herein as an elongatefunnel sheath 3502 or the elongate sheath 3502, having a proximal end3504 and a distal end 3506. The elongate funnel member 3502 can beelastic and/or flexible. The elongate funnel member 3502 can compriseany desired length and any desired diameter. In some embodiments, theelongate funnel member 3502 can have an outer diameter of at least 10French, at least 12 French, at least 14 French, at least 18 French, atleast 20 French, at least 22 French, between 14 French and 24 French,between 15 French and 21 French, between 16 French and 22 French, and/orany other or intermediate size.

The elongate funnel member 3502 can comprise a radiopaque marker thatcan be, for example, part of the distal end 110 of the elongate funnelmember 3502. The elongate funnel member 3502 defines a lumen extendingbetween the proximal end 3504 and the distal end 3506. The lumen of theelongate funnel member 3502 can be sized to slidably receive thethrombus extraction catheter 104. In some embodiments, the lumen of theelongate member 106 can have an internal diameter of at least 2 French,at least 10 French, at least 14 French, at least 18 French, at least 20French, at least 22 French, between 11 French and 12 French, between 10French and 22 French, between 14 French and 21 French, between 16 Frenchand 20 French, and/or any other or intermediate size. The lumen canterminate at a sealed aperture 3508, also referred to herein as a sealedhub 3508, located at the proximal end 3504 of the elongate funnel member3502. In some embodiments, the sealed aperture 3508 can be self-sealingand/or can comprise a self-sealing seal.

The elongate funnel member 3502 can further include an aspiration port3510 that can be at the proximal end 3504 of the elongate funnel member3502 and/or connected to the proximal end 3504 of the elongate funnelmember 3502 via, for example, a connecting tube 3512. In someembodiments, the aspiration port 3510 can be a part of, and/or connectedto the sealed hub 3508. In some embodiments, the aspiration port 3510can be selectively fluidly connected to the lumen via, for example, avalve 3514, also referred to herein as an aspiration valve 3514, whichvalve 3514 can be a tubing clamp that can be located at a position alongthe connecting tube 3512 between the lumen and the aspiration port 3510.

The elongate funnel member 3502 can further hold a dilator assembly3516. The dilator assembly 3516 can be configured to hold theself-expanding funnel 1708 that can be attached to the distal end 3506of the elongate funnel member 3502 in a constrained configuration, andto release the self-expanding funnel 1708 from that constrainedconfiguration. The dilator assembly 3516, as shown in FIG. 36, cancomprise a proximal end 3518, and a distal end 3520. The dilatorassembly 3516 can further include an obturator 3522 having a proximalend 3524, a distal end 3526, and an elongate shaft 3528 extendingtherebetween. In some embodiments, the dilator assembly 3526 can have alength that is greater than a length of the elongate funnel member 3502,and in some embodiments, the elongate shaft 3528 can have a length thatis greater than a length of the elongate member 3502 of the funnelcatheter 3500. The obturator 3522 can further define a lumen extendingthrough the obturator 3522, which lumen can receive a guidewire. In someembodiments, the guidewire can comprise any desired dimensions and can,in some embodiments, have a diameter of approximately 0.035 inches, adiameter of approximately 0.018 inches, a diameter of less thanapproximately 0.1 inches, and/or a diameter of less than approximately0.05 inches. The dilator assembly 3516 can be sized and shaped so as tobe able to slidably move through the lumen of the elongate member 3502.

The obturator 3522 can include the capture sheath 1500 that canproximally extend from the distal end 3526 of the obturator 3522, andthe tip such as the atraumatic tip 1502 located at the distal end 3526of the obturator 3522. The atraumatic tip 1502 can be radiopaque. Theobturator 120 can further include the connection fitting 1504 that canbe located at the proximal end 1506 of the capture sheath 1500. In someembodiments, the connection fitting 1504 can be configured to sealinglyconnect with the distal end 3506 of the elongate funnel member 3502 ofthe funnel catheter 3500.

The obturator 3522 can further include a stop portion 1508 located atthe proximal end 3524 of the obturator 3522. In some embodiments, thestop portion 1508 can have a diameter larger than the lumen of theelongate funnel member 3502 of the funnel catheter 3500 and/or largerthan the diameter of the sealed aperture 3508 so as to prevent the stopportion 1508 from entering into the lumen of the elongate funnel member3502 and/or the sealed aperture 3508.

The dilator assembly 3516 can further include an advancing sheath 3530,also referred to herein as the moveable sheath 3530, that can, in someembodiments, extend, coaxially along a portion of the elongate shaft3528 of the obturator 3522 between, for example, the proximal end 3524and the distal end 3526 of the obturator 3522, and specifically betweenthe stop portion 1508 and the proximal end 1506 of the capture sheath1500. The advancing sheath 3530 can include a proximal end 3532, adistal end 3534, and a tubular shaft 3536 extending between the proximalend 3532 and the distal end 3534 of the advancing sheath 3530. Thetubular shaft 3536 can define a lumen that can be sized to receive theobturator 3522 such that the advancing shaft 3530 is axiallydisplaceable along the obturator 3533 from a loading position, as shownin FIG. 36, to a retracting position, as shown in FIG. 37. In someembodiments, the advancing sheath 3530 in the loading position isrelatively more proximal with respect to the obturator 3522 than theadvancing sheath 3530 in the retracting position.

The advancing sheath 3530 further comprises a stop 3538 located at theproximal end 3532 of the advancing sheath 3530. The stop 3538 caninteract with one or several features of the obturator 3522 to securethe advancing sheath 3530 to the obturator 3522 and secure the relativeposition of the advancing sheath 3530 with respect to the obturator3522. In some embodiments, for example, the stop 3538 can engage with alock 3540 that can be, for example, connected to the stop portion 1508of the obturator 3522.

The advancing sheath 3530 can further comprise mating features 3542 thatcan be, for example, located on the distal end 3534 of the advancingsheath 3530. The mating features 3542 can be sized, shaped, andconfigured to engage with the proximal end 1506 of the capture sheath1500, and specifically with the connection fitting 1504 of the capturesheath 1500. In some embodiments, the mating features 3542 can beconfigured to sealingly connect with the connection fitting 1504 of thecapture sheath. In some embodiments, the advancing sheath 3530 can havean outside diameter that is equal or approximately equal to an outsidediameter of the capture sheath 1500.

With reference to FIGS. 38-A to 38-D, a process for deploying theself-expanding funnel 1708 is shown. The process can include providingthe dilator assembly 3516 and the funnel catheter 3500 with the funnel1708 affixed to the distal end 3506 of the funnel catheter 3500. In FIG.38-A, the funnel catheter 3500 including the elongate funnel member 3502is shown. The dilator assembly 3516 including the obturator 3522 and theadvancing sheath 3530 in the loading position such that the stop 3538 ofthe advancing sheath 3530 engages with and/or is engaged with the lock3540 of the obturator 3522. As seen in FIG. 38-A, the funnel 1708 iscontained in a constrained configuration within the capture sheath 1500.When performed in a patient, the funnel catheter 3500 can be used topercutaneously access a venous vessel of a patient through, for examplean access site that can be, for example, the popliteal access site, thefemoral access site, or the internal jugular access site. In someembodiments, the funnel catheter can percutaneously access the venousvessel via an introducer sheath 102 inserted into the venous vessel atthe access site. In some embodiments, percutaneously accessing thevenous vessel via the introducer sheath can include inserting the funnelcatheter 3500 into the venous vessel through the introducer sheath. Thedistal end 3506 of the funnel catheter 3500 can be advanced within thevenous vessel to a position proximate to a thrombus, and in someembodiments, the distal end 3506 of the funnel catheter 3500 can beadvanced within the venous vessel to a position proximal to a thrombus.

In FIG. 38-B, the self-expanding funnel 1708 is deployed from theconstrained configuration with the capture sheath 1500 to an expandedconfiguration free of the capture sheath 1500. This can include distallyadvancing the capture sheath 1500 relative to the funnel catheter 3500to unsheathe the self-expanding funnel 1708 from the constrainedconfiguration to the unconstrained configuration. In some embodiments,distally advancing the capture sheath 1500 can include distallyadvancing the dilator assembly 3516 relative to the funnel catheter3500. In some embodiments, the deployment of the self-expanding funnel1708 can include proximally retracting the elongate sheath 3502 over theobturator 3522 and/or the dilator assembly 3516 to unsheathe theself-expanding funnel 1708 from the constrained configuration to theexpanded configuration.

After the self-expanding funnel 1708 has been deployed, and as depictedin FIG. 38-C, the advancing shaft 3530 can be displaced from the loadingposition to the retracting position. In some embodiments, thisdisplacement of the advancing shaft 3530 can occur via the proximalretraction of the obturator 3522 relative to the advancing shaft 3530,and in some embodiments, this displacement of the advancing shaft 3530can occur via the distal advance of the advancing shaft 3530 relative tothe obturator 3522. In some embodiments, the advancing shaft can bedisplaced from the loading position to the retracting position such thatthe mating features 3542 engage with the proximal end 1506 of thecapture sheath 1500, and specifically with the connection fitting 1504of the capture sheath 1500. In some embodiments, the positioning of theadvancing sheath 3530 in the retracting position can prevent damagecaused by the capture sheath 1500 or other components of the obturator3522 during retraction of the obturator 3522 from the funnel catheter3500. Specifically, the positioning of the advancing sheath 3530 in theretracting position provides a constant diameter of portions of thedilator assembly 3516 that retract through the sealed hub 3508.

After moving the advancing shaft 3530 to the retracting position, and asshown in FIG. 38-D, the dilator assembly 3516 can be retracted from thefunnel catheter 3500. In some embodiments, the dilator assembly 3516 canbe proximally retracted through the lumen of the funnel catheter 3500,and out the sealed hub 3508 of the funnel catheter 3500. In someembodiments in which the funnel catheter 3500 is used to access thevenous vessel, the thrombus extraction catheter 104 constraining the TED202 can be inserted into the venous vessel through the lumen of theelongate sheath 3502 of the funnel catheter 3500. In some embodiments,the thrombus extraction catheter 104 can be inserted into the venousvessel and advanced through the venous vessel until a distal tip 132 ofthe thrombus extraction catheter 104 is proximate to the thrombus, andin some embodiments, until the distal tip 132 of the thrombus extractioncatheter 104 is distally past the thrombus or a portion of the thrombus.The TED 202 can then be deployed and proximally retracted relative tothe funnel catheter 3500 to separate thrombus from the walls of thevenous vessel and to capture thrombus within the TED 202. The TED 202can be proximally retracted relative to the funnel catheter 3500 untilan opening 414 of the thrombus extraction device 202 is within theself-expanding funnel 1708. The thrombus extraction device 202 can thenbe retracted through the funnel catheter 3500, or in some embodiments,the thrombus extraction device 202 can be maintained such that theopening 414 of the TED 202 remains in the funnel 1708 while the TED 202and the funnel catheter 3500 are simultaneously withdrawn from thepatient through the inserter sheath. In some embodiments, thrombus canbe captured within the self-expanding funnel 1708, and the thrombus canbe aspirated out of the patient via the funnel catheter 3500, andspecifically via the lumen of the funnel catheter 3500, the connectingtube 3512, and the aspiration port 3510.

With reference now to FIG. 39, a top view of one embodiment of thethrombus extraction device 202 is shown. Specifically, FIG. 39 is a topview of one embodiment of the thrombus extraction device 202 with theexpandable cylindrical portion 208 in an at least partially stackedconfiguration. The self-expanding coring element 206 is connected viathe connection member 415 at the proximal end 210 of the self-expandingcoring element 206 to the distal end 212 of the coring element shaft140. As seen in FIG. 39, the coring element shaft 140, which can includeradiopaque marker 2450, extends from the distal end 204 of the outershaft 138.

The proximal end 216 of the expandable cylindrical portion 208 connectsto the distal end 214 of the self-expanding coring element 206. In someembodiments, the expandable cylindrical portion 208 and specifically theproximal end 216 of the expandable cylindrical portion 208 is formedand/or woven on the distal end 214 of the self-expanding coring element206 to thereby form a unitary thrombus extraction device 202, alsoreferred to herein as an interwoven thrombus extraction device 202. Thedistal end 217 of the expanding cylindrical portion 208 connects to thedistal end 218 of the tip shaft 200.

In some embodiments, and as seen in FIG. 39, the self-expanding coringelement 206 can engage with all or portions of the stop shaft 3000 toaffect the expansion of the self-expanding coring element 206.Specifically, in some embodiments, the self-expanding coring element 206can include one or several features that can together form the expansionmechanism. 701, which expansion mechanism can include the ring 700 andthe stop 702. The ring 700 can, in some embodiments, be the samematerial as the self-expanding coring element 206 or can be a differentmaterial than the self-expanding coring element 206. The ring 700 can beintegrally formed with the self-expanding coring element 206 and/or canbe attached to the self-expanding coring element via, for example, oneor several welds, adhesive, one or several mechanical fasteners, or thelike. The ring 700 can have a diameter larger than the diameter of thestop shaft 3000 such that the ring 700 is slidable along the stop shaft3000, or in some embodiments, the ring 700 can have a diameter less thanthe diameter of the stop shaft 3000 such that the ring 700 is connectedto the stop shaft 3000 via an interference fit that secures and/orpartially secures the position of the ring 700 with respect to the stopshaft 3000.

The stop 702 can comprise a variety of shapes and sizes and can be madefrom a variety of materials. In some embodiments, the stop 702 cancomprise a polymeric member and/or metallic member that is affixed to aportion of the stop shaft 3000. The stop 702 can, in some embodiments,have the form of a tab, a protrusion, a flange, a ridge or the like. Insome embodiments, the stop 702 can be sized and shaped to engage withthe ring 700 to thereby apply proximally directed force to theself-expanding coring element 206 when stop shaft 3000 is proximallydisplaced relative to the self-expanding coring element 206. In someembodiments, the stop shaft 3000 can be displaced via, for examplemovement of the plunger 154 to the second position and/or displacementof the shuttle to a second position. In some embodiments, the shuttlecan be attached to a spring, such as a constant force spring, which cancause this displacement of the shuttle. In some embodiments, at leastthe portion of the self-expanding coring element 206 located between thering 700 and the connection member 415 can be forcibly expanded by theapplication of this proximally directed force to ring 700, therebymoving the self-expanding coring member 206 to full expansion. In otherembodiments, the engagement of the ring 700 and the stop 702 can connectthe thrombus extraction device 202 to the spring, thereby bringing theTED 202 to full expansion. In another embodiment, the expansionmechanism 701 does not include the ring 700 and the stop 702 is notattached the stop shaft 3000, rather, the expansion mechanism 701comprises a wire or filament that can be, for example, a metallic orpolymeric material. The wire or filament wraps through theself-expanding coring element 206 and can be attached such as fixedlyattached to the stop shaft 3000. In some embodiments, for example, theterminating end of the filament can be fixed to the stop shaft 3000 viaa compression or tension spring, which spring allows the self-expandingcoring element 206 to reduce in diameter slightly without disengagingthe stop 702. In some embodiments, the wire or filament is comprised ofan elastic material to include the functionality of the compression ortension spring.

The expandable cylindrical portion 208 can comprise the braided filamentmesh structure 704 that can be configured to capture thrombus. In someembodiments, the braided filament mesh structure can be coextensive withthe expandable cylindrical portion 208 and thus can share a proximal end216 and/or a distal end 217. In the embodiment shown in FIG. 7, thebraided filament mesh structure 704 can be a braid of elastic filamentshaving a generally tubular, elongated portion 706 and a distal taperedportion 708. In embodiments in which the expandable cylindrical portion208 is at least partially stacked, the expandable cylindrical portion208 can further include a proximal tapered portion 710. In otherembodiments, the braided filament mesh structure 704 can be any porousstructure and/or can have other suitable shapes, sizes, andconfigurations (e.g., the distal portion 708 can be generallycylindrical, etc.).

In some embodiments, the tip shaft 200 is moveable relative to thecoring element shaft 140 to thereby allow the changing of the length ofthe expandable cylindrical portion 208. In some embodiments, and asdiscussed above, the change in the length of the expandable cylindricalportion 208 can result in the movement of the expandable cylindricalportion 208 between two or more of: a stacked configuration; an expandedconfiguration; and a collapsed configuration. In some embodiments, thechange in the configuration of the expandable cylindrical portion 208can result in a change of diameter of the expandable cylindrical portion208. Specifically, in some embodiments, the expandable cylindricalportion 208 can have a diameter in the stacked configuration that isgreater than a diameter of the self-expanding coring element 206. Insome embodiments, the diameter of the expandable cylindrical portion 208can be between 1 mm and 20 mm larger than the diameter of theself-expanding coring element 206, can be between 2 mm and 10 mm largerthan the diameter of the self-expanding coring element 206, and/or canbe between 2 mm and 6 mm larger than the diameter of the self-expandingcoring element 206.

With reference now to FIG. 40, a section view of one embodiment of thehandle 134 is shown. The handle 134 includes a distal end 142 and aproximal end 144. The coring element shaft 140 connects to the distalend 142 of the handle 134 and distally extends away from the handle 134.A lock feature 146 is located at the distal end 142 of the handle 134.The lock feature 146 can be configured to engage with a component and/orportion of the outer shaft 138 to secure the outer shaft 138 to thehandle 134. In some embodiments, the outer shaft 138 can be proximallyslid over the coring element shaft 140 and secured to the handle via thelocking feature to deploy and/or partially deploy the thrombusextraction device 202. The handle can further include the second flushport 156. The second flush port 156 can be fluidly connected to aninternal portion of the handle 134 and thereby connect to the lumen ofthe coring element shaft 140 so as to allow the flushing of the lumen ofthe coring element shaft 140.

The handle 134 can include a housing 1200 that defines an internalvolume 1202. As seen in FIG. 40, the stop shaft 3000 extends through thelumen of the coring element shaft 140 into the internal volume 1202 ofthe handle 134 and connects to, and/or is coupled to a shuttle 4000 thatslides along a track 4002 within the housing 1200 of the handle 134. Theshuttle 4000 is moveable between a first position relatively moreproximate to the distal end 142 of the handle 134 and a second positionrelatively more proximate to the proximal end 144 of the handle 134. Insome embodiments, the shuttle 4000 can be located in the first positionwhen the self-expanding coring element 206 is in an undeployedconfiguration, and the shuttle 4000 can be located in the secondposition when the self-expanding coring element 206 is at fullexpansion. In some embodiments, the movement of the shuttle 4000 fromthe first position to the second position can move the thrombusextraction device 202, and specifically the self-expanding coringelement 206 to an expanded state, which expanded state can be fullexpansion.

The shuttle 4000 can be connected to and/or coupled to a forcegeneration component such as, for example, a spring 4004. The spring4004 can comprise, for example, a compression spring, a tension spring,a torsion spring, or a constant force spring such as a watch spring. Insome embodiments, the spring 4004 can apply a force to the shuttle 400to bias the thrombus extraction device 202, and specifically theself-expanding coring element 206 to the expanded state and morespecifically to hold the thrombus extraction device 202, andspecifically the self-expanding coring element 206 in full expansion.

As seen in FIG. 40, the tip shaft 200 can extend into and/or through thehandle 134. In some embodiments, for example, the tip shaft 200, and/ora feature connected to the tip shaft 200 such as a plunger, can extendthrough the handle 134. In some embodiments, the extension of the tipshaft 200 and/or feature connected to the tip shaft 200 through thehandle 134 can allow the control of the position of the tip shaft 200with respect to one or more of the other shafts 138, 140, 3000, 3002and/or with respect to the handle 134 or the self-expanding coringelement 206. In some embodiments, this control of the relative positionof the tip shaft 200 likewise controls the expandable cylindricalportion 208, and specifically controls the braided filament meshstructure 704. In some embodiments, this control can enable movement ofthe expandable cylindrical portion 208, and specifically controls thebraided filament mesh structure 704 between collapsed, expanded, andstacked configurations.

Due to the connection of the braided filament mesh structure 704 to thedistal end 218 of the tip shaft 200, axial movement of the tip shaft 200radially expands/shortens or collapses/lengthens the braided filamentmesh structure 704 of the TED 200. For example, so long as the coringelement shaft 140 is fixed and/or limited to axial movement at a rateless than that of the tip shaft 200: (1) distal movement of the tipshaft 200 stretches the braided filament mesh structure 704 along itslongitudinal axis such that the radius of the braided filament meshstructure 704 decreases and the length of the braided filament meshstructure 704 increases; and (2) proximal movement of the tip shaft 200compresses the braided filament mesh structure 704 along itslongitudinal axis such that the radius of the braided filament meshstructure 704 increases and the length of the braided filament meshstructure 704 decreases. The filament mesh structure 704 can bepositioned in a plurality of configurations including, for example, astacked configuration, a collapsed configuration, and an expandedconfiguration. The filament mesh structure 704 in the stackedconfiguration can have a shorter length than the filament mesh structure704 in the expanded configuration, and the filament mesh structure 704in the expanded configuration can have a shorter length the filamentmesh structure 704 in the collapsed configuration. In certainembodiments, the braided filament mesh structure 704 can have anydesired length in the collapsed configuration, including, for example, alength in the collapsed configuration between approximately 1 and 80inches, between 2 and 60 inches, between 3 and 50 inches, betweenapproximately 5 and 30 inches, between approximately 10 and 20 inches,and/or of approximately 16 inches, and in some embodiments, the braidedfilament mesh structure 704 can have a length in the expandedconfiguration of between approximately 1 and 25 inches, betweenapproximately 10 and 20 inches, and/or of approximately 11 inches. Insome embodiments, the filament mesh structure 704 can have any desiredlength in the stacked configuration including, for example, a lengthbetween 1 and 50 inches, a length between 1 and 30 inches, a lengthbetween 1 and 20 inches, a length of between 1 and 15 inches, between 2and 10 inches, and/or of approximately 5 inches in the stackedconfiguration.

In some embodiments, the braid angles of the filament mesh structure 704can change between configurations. As the length of the filament meshstructure 704 increases, the braid angle θ can decrease, and as thelength of the filament mesh structure 704 decreases, the braid angle θcan increase. In some embodiments, the braid angle θ of the filamentmesh structure 704 can be less than approximately 10°, less thanapproximate 20°, less than approximately 30°, less than approximately40°, and/or less than approximately 50° when the filament mesh structure704 is in the collapsed configuration. In some embodiments, the braidangle of the filament mesh structure 704 can be between 20° and 85°,between 30° and 70°, between 35° and 60°, between 40° and 50°, and/orapproximately 45° when the filament mesh structure 704 is in theexpanded configuration. In some embodiments, the braid angle of thefilament mesh structure 704 can be greater than approximately 45°,greater than approximately 60°, greater than approximately 70°, and/orgreater than approximately 80° when the filament mesh structure 704 isin the stacked configuration.

With reference now to FIGS. 41-A to 41-F, views depicting one embodimentof a process for expanding a stackable thrombus extraction device 202 ina blood vessel 2200 is shown. In some embodiments, the process of FIGS.41-A to 41-F, can be performed as a part of, or in the place of theprocess shown in FIGS. 23-A to 23-H. In some embodiments, the portion ofthe process shown in FIGS. 41-E and 41-F can be performed in the placeof steps 23, and particularly in the place of steps 23-G and 23-H. Insome embodiments, the process of FIGS. 41-A to 41-F can be performed asa part of or in the place of the process of FIGS. 24-A and 24-B, or ofFIGS. 25-A to 25-H. In some embodiments, for example, the process ofFIGS. 41-A to 41-F can advantageously eliminate the necessity ofperforming the process of FIGS. 24-A and 24-B as the expandablecylindrical portion 208 of the thrombus extraction device 202 can becontrolled to limit the extension of the thrombus extraction device 202beyond the thrombus 2200. This benefit of the process of FIGS. 41-A to41-F is particularly advantageous when the thrombus 2200 forms proximateto a feature 3400.

The process for expanding a stackable thrombus extraction device 202 ina blood vessel 2200 can be performed using all or portions of thethrombus extraction system 100. In some embodiments, the processexpanding a stackable thrombus extraction device 202 in a blood vessel2200 can be performed in connection with a monitoring technique, such asfluoroscopy, angiography, and/or ultrasonic monitoring. In someembodiments, the monitoring technique can be used to monitor thedeployment of the thrombus extraction device 202 in the vessel viaobservation of the one or several radiopaque markers located on theintroducer sheath 102 and/or the thrombus extraction catheter 104.

The process begins at FIG. 41-A, wherein the thrombus 2200 is identifiedin the blood vessel 2202 such as venous vessel. In some embodiments, thethrombus 2200 can be located in the peripheral vasculature of thepatient's body. The thrombus 2200 can comprise the proximal end 2204 andthe distal end 2206. In some embodiments, the identification of theblood vessel 2202 can further include the determination of whether thethrombus 2200 in the blood vessel 2202 is suitable for thrombusextraction. In some embodiments, the thrombus 2200 in the blood vessel2202 can be suitable for extraction when the blood vessel 2202 has adiameter of at least 3 millimeters. In some embodiments, the thrombus2200 in the blood vessel 2202 can be suitable for extraction when theblood vessel 2202 has a diameter of at least 3 millimeters and is atleast one of a femoral vein, an iliac vein, a popliteal vein, aposterior tibial vein, an anterior tibial vein, or a peroneal vein. Insome embodiments, and as part of identifying the thrombus 2200, afeature 3400 can be identified, which feature 3400 can be located distalof the distal end 2206 of the thrombus 2200.

After the thrombus 2200 has been identified, a guidewire 3402 can beinserted through the blood vessel 2202, through the thrombus 2200, andin some embodiments, through the feature 3400. In some embodiments, theguidewire 3402 can be inserted into the blood vessel, as shown in FIG.34-A, via an access site such as, for example, the internal jugular (U)access site, the femoral access site, the popliteal access site, orother venous or arterial access sites. In some embodiments, theguidewire 3402 can be inserted using one or several imaging and/ormonitoring techniques including, for example, fluoroscopy, angiography,and/or ultrasonic monitoring.

After the thrombus has been identified, and as shown in FIG. 41-A, theintroducer sheath 102 is advanced, either with or against the directionof blood flow in the blood vessel, such that the distal end 110 of theintroducer sheath 102 and/or the obturator 120 is proximate to thethrombus 2200, and particularly is proximate to the thrombus 2200 at aposition proximal of the thrombus 2200. In some embodiments, this caninclude providing the introducer sheath 102 which can include a dilatorshaft 4100 extending through the lumen of the elongate member 106 of theintroducer sheath 102. In some embodiments, the dilator shaft 4100 canseal, or partially seal the lumen of the elongate member 106 at thedistal end 110 of the introducer sheath 102. In some embodiments, theintroducer sheath 102 inserted in FIG. 41-A can be used in connectionwith the funnel catheter 3500. In some embodiments, such an introducersheath 102 used with the funnel catheter 3500 can include a funnel 1708,and in some embodiments, the introducer sheath 102 used with the funnelcatheter 3500 does not include a funnel 1708. The introducer sheath canpercutaneously access the circulatory system of the patient andspecifically the peripheral vasculature including, for example, anartery, and a blood vessel or venous vessel of the patient via an accesssite 2208 which can be one of the above referenced access sites.

After the introducer sheath 102 has been advanced to a desired position,the self-expanding funnel 1708 can be deployed and/or unsheathed fromthe constrained configuration to the expanded configuration as depictedin FIG. 41-B. In some embodiments, this can include percutaneouslyaccessing the venous vessel of the patient by inserting the funnelcatheter 3500 into the venous vessel via the access site. In theembodiment of FIG. 41-B, percutaneously accessing the venous vessel ofthe patient with the funnel catheter 3500 can include inserting thefunnel catheter 3500 into the venous vessel through the introducersheath. The distal end 3506 of the funnel catheter 3500 can be advancedwithin the venous vessel to a position proximate to a thrombus, and insome embodiments, the distal end 3506 of the funnel catheter 3500 can beadvanced within the venous vessel to a position proximal to a thrombus.After the funnel catheter 3500 has reached the desired position, thefunnel 1708 can be deployed as described with respect to FIGS. 38-A to38-D.

After the self-expanding funnel 1708 has been deployed, a portion of thethrombus extraction catheter 104 such as the outer shaft 138 can beinserted into the lumen 1701 of the introducer sheath 102 via the sealedaperture 112. In some embodiments, this can include providing thethrombus extraction catheter 104 which comprises the thrombus extractiondevice 202. In some embodiments, the thrombus extraction device 202 canbe constrained within the outer shaft 138 and can inserted, togetherwith the outer shaft 138, into the lumen of the elongate member 106 viathe sealed aperture 112. In some embodiments, the outer shaft 138 of thethrombus extraction catheter 104 can have a diameter so as to dilate theseal of the sealed aperture 112 such that the sealed aperture 112 sealsaround and seals to the outer shaft 138.

After the outer shaft 138 has been inserted into the lumen 1701 of theintroducer sheath 102, a portion of the thrombus extraction catheter 104can be inserted via the introducer sheath 102 into the blood vessel2202. In some embodiments, the distal end 132 of the thrombus extractioncatheter 104 can be advanced to a position proximate to the thrombus2200 and/or to a position proximal to the thrombus 2200. In someembodiments, the insertion and/or advance of the thrombus extractioncatheter 104 can be monitored and specifically can be fluoroscopicallymonitored. In some embodiments, the position of one or severalradiopaque markers, including radiopaque marker 222 of the thrombusextraction catheter 104 can be monitored.

After the portion of the thrombus extraction catheter 104 has beeninserted into the blood vessel 2202, a portion of the thrombusextraction catheter 104 can be distally advanced through the clot 2200as depicted in FIG. 41-C. In some embodiments, this distal advancethrough the clot 2200 can be either with or against the direction ofblood flow. In some embodiments, the portion of the thrombus extractioncatheter 104 distally advanced through the clot 2000 can contain and/orconstrain the thrombus extraction device 202. In some embodiments,distally advancing the portion of the thrombus extraction catheter 104through the clot can include advancing the portion of the thrombusextraction catheter 104 until the radiopaque marker 222, that can befluoroscopically monitored and that can be located at the distal end 218of the tip shaft 200, is distally past the thrombus 2200 and/or aportion of the thrombus 2200.

After the portion of the thrombus extraction catheter 104 is distallyadvanced through the clot 2200, the thrombus extraction device 202 canbe partially deployed as depicted in FIG. 41-D. In some embodiments, thethrombus extraction device 202 can be partially deployed by eitheradvancing a portion of the thrombus extraction device 202 beyond thedistal end 204 of the outer shaft 138 or by retracting the outer shaft138 relative to the thrombus extraction device 202 until a portion ofthe thrombus extraction device 202 is beyond the distal end 204 of theouter shaft 138. In some embodiments, the thrombus extraction device canbe partially deployed such that a portion of the thrombus extractiondevice 202 is distally past the thrombus 2200 and/or distally past adesired portion of the thrombus 2200.

In some embodiments, the portion of the thrombus extraction device 202is advanced beyond the distal end 204 of the outer shaft 138 by distallyadvancing the coring element shaft 140 with respect to the outer shaft138. In some embodiments, the coring element shaft 140 can be distallyadvanced until the lock feature 146 contacts the mating feature 148, andthe lock feature 146 can be mated and/or secured to the mating feature148 to fix the relative position of the coring element shaft 140 withrespect to the outer shaft 138.

In some embodiments, the partial deployment of the thrombus extractiondevice 202 can be monitored, and specifically, the deployment of thethrombus extraction device 202 can be fluoroscopically monitored via,for example, the radiopaque marker 222 and the radiopaque marker locatedat one or both of the distal end 204 of the outer sheath 138 and thedistal end 212 of the coring element sheath 140 such as, for exampleradiopaque marker 2450. In some embodiments, the partial deployment ofthe thrombus extraction device 202, and specifically the advancing ofthe thrombus extraction device 202 beyond the distal end 204 of theouter shaft 138 or retracting the outer shaft 138 relative to thethrombus extraction device 202 can be ceased based on a position thedistal end 204 of the outer sheath 138 comprising the radiopaque marker(first radiopaque marker) relative to the radiopaque marker 222 locatedon the thrombus extraction device 202 (second radiopaque marker).

In some embodiments, the coring element shaft 140 and/or the tip shaft200 can be manipulated so that a desired portion of the thrombusextraction device 202, and specifically of the expandable cylindricalportion 208 of the thrombus extraction device 202 extends beyond theouter shaft 138. In some embodiments, this can comprise any desiredextension of the thrombus extraction device 202 beyond the outer shaft138 including, for example, the extension of less than approximately 20inches of the thrombus extraction device 202 beyond the outer shaft 138,the extension of less than approximately 16 inches of the thrombusextraction device 202 beyond the outer shaft 138, the extension of lessthan approximately 10 inches of the thrombus extraction device 202beyond the outer shaft 138, the extension of less than approximately 5inches of the thrombus extraction device 202 beyond the outer shaft 138,the extension of less than approximately 2 inches of the thrombusextraction device 202 beyond the outer shaft 138, or the extension ofless than approximately 2 inches of the thrombus extraction device 202beyond the outer shaft 138.

In some embodiments, the thrombus extraction device 202 can be partiallydeployed until the thrombus extraction device 202, and specificallyuntil the distal end 217 of the cylindrical portion 208 of the thrombusextraction device 202 reaches a desired position, such as, for example,a desired position with respect to a feature 3400 of the blood vessel2202 or with respect to an anatomical structure such as, for example,valve. In some embodiments, this feature 3400 of the blood vessel cancomprise a transition, such as a branch point, from one blood vessel toanother, a desired diameter of the blood vessel, or the like. In someembodiments, the thrombus extraction device 202 can be deployed untilthe distal end 217 of the cylindrical portion 208 of the thrombusextraction device 202 reaches a desired point beyond a branch point of avessel such that the cylindrical portion 208 is wholly or partiallycontained in a different blood vessel, or a blood vessel having a largerdiameter than the remaining portions of the thrombus extraction device202. In some embodiments, when the distal end 217 of the cylindricalportion 208 of the thrombus extraction device 202 reaches this desiredposition, the tip shaft 200 can be pinned and the position of the distalend 217 of the cylindrical portion 208 of the thrombus extraction device202 can be maintained.

After the thrombus extraction device 202 is partially deployed, aportion of the thrombus extraction device 202 can be stacked.Specifically, in some embodiments, the deployed portion of the thrombusextraction device can include all or portions of the cylindrical portion208 of the thrombus extraction device 202, and specifically of thefilament mesh structure 704. In some embodiments, the deployed portionsof the cylindrical portion 208 of the thrombus extraction device 202,and specifically of the filament mesh structure 704 can be stacked, orpartially stacked as depicted in FIG. 41-E. In some embodiments, thisstacking can be achieved by relatively distally advancing the coringelement shaft 140 with respect to the tip shaft 200, which can changethe braid angle θ, decrease the length of the cylindrical portion 208 ofthe thrombus extraction device 202, and specifically of the filamentmesh structure 704, and increase the diameter of the cylindrical portion208 of the thrombus extraction device 202, and specifically of thefilament mesh structure 704. In some embodiments, this stacking canoccur while the tip shaft 200 is pinned and/or while the position of thedistal end 217 of the cylindrical portion 208 of the thrombus extractiondevice 202 is maintained at a desired location.

The deployment of the thrombus extraction device 202 can be continueduntil the thrombus extraction device 202 is deployed from the outershaft 138 as shown in FIG. 41-F. In some embodiments, this can beachieved vie the continued distal advancement of the coring elementshaft 140 which can be, in some embodiments, a relative distaladvancement with respect to the tip shaft 200 and/or the outer shaft138. In some embodiments, this continued deployment of the thrombusextraction device 202 can cause the continued stacking of portions ofthe cylindrical portion 208 of the thrombus extraction device 202, andspecifically of the filament mesh structure 704.

With reference now to FIGS. 42-A and 42-B, views depicting oneembodiment of a process for retracting stackable thrombus extractiondevice 202 through thrombus in a blood vessel 2200 is shown. The processof FIGS. 42-A and 42-B, can be performed as a part of, or in the placeof the process shown in FIGS. 25-A to 25-H.

After the thrombus extraction device 202 is deployed, or as part of thedeployment of the thrombus extraction device 202, the thrombusextraction device 202 can be fully expanded. In some embodiments, thiscan include allowing the full expansion of the thrombus extractiondevice 202 such that the thrombus extraction device 202 engages a wall2220 of the blood vessel 2202. In some embodiments, the thrombusextraction device 202 can be fully expanded by moving the plunger 154from the first position to the second position and securing the plunger154 in the second position to thereby fix the relative position of thestop shaft 3000 with respect to the coring element shaft 140. In someembodiments, the movement of the plunger 154 from the first position tothe second position proximally retracts the stop shaft 3000 with respectto the coring element shaft 140 to thereby fully expand the expandablecylindrical portion 208 of the thrombus extraction device 202. Theproximal retraction of the stop shaft 3000 with respect to the coringelement shaft 140 can further bring the stop 702 into engagement withthe ring feature 700 to thereby fully expand the self-expanding coringelement 206. In some embodiments, the securing of the plunger 154 in thesecond position can secure the self-expanding coring element 206 and thethrombus extraction device 202 in full expansion via the engagement ofthe stop 702 with the ring feature 700.

In some embodiments, the thrombus extraction device can be fullyexpanded by the movement of the shuttle 4000 from the first position tothe second position. In some embodiments, the shuttle 4000 can be movedalong the track 4002 by the spring 4004 to thereby move the stop shaft3000 with respect to the self-expanding coring element 206. In someembodiments, this movement of the stop shaft 3000 can bring the stop 702into engagement with the ring feature 700 to thereby fully expand theself-expanding coring element 206. In some embodiments, the spring 4004can secure the self-expanding coring element 206 and the thrombusextraction device 202 in full expansion via the engagement of the stop702 with the ring feature 700. In some embodiments, the shuttle 4000moves from the first position to the second position until compressiveforces applied to the self-expanding coring element 206 equal theexpansive forces of the self-expanding coring element 206 and of thespring 4004. In some embodiments, these compressive forces equal theexpansive forces when the self-expanding coring element 206 engages thewall 2220 of the blood vessel 2202.

After the thrombus extraction device 202 is at full expansion, thethrombus extraction device 202 can be proximally retracted through thethrombus 2200 as shown in FIG. 42-B. In some embodiments, the proximalretraction of the thrombus extraction device 202 can be, for example, ina direction of blood flow through the blood vessel 2202 or against thedirection of blood flow through the vessel 2202. In some embodiments,the proximal retraction of the thrombus extraction device 202 throughthe thrombus 2200 can result in the capture of the distal end 2206 ofthe thrombus 2200 before the capture of the proximal end 2204 of thethrombus 2200.

In some embodiments, the proximal retraction of the thrombus extractiondevice 202 can result in the separation and/or coring of at least aportion of the thrombus 2200 from the wall 2220 of the blood vessel 2202by, for example, the self-expanding coring element 206 and/or the stentportion, and the capture of that separated portion of the thrombus 2200within the expandable cylindrical portion 208. In some embodiments, theexpandable cylindrical portion 208 can be formed of the braided filamentmesh structure that can be, for example, a net-like filament meshstructure. In some embodiments, a portion of the thrombus can becaptured within the expandable cylindrical portion 208 by entering theexpandable cylindrical portion 208 via the mouth 414 of theself-expanding coring element 206 and/or via one or several of theinterstices 404 of the self-expanding coring element 206.

The distal end 2206 of the thrombus 2200 is separated and/or cored fromthe walls 2220 of the blood vessel 2202 by the self-expanding coringelement 206 via the proximal retraction of the thrombus extractiondevice 202, and the thrombus 2200 is captured in the expandablecylindrical portion 208 of the thrombus extraction device 202 by thecontinued proximal retraction of the thrombus extraction device throughthe thrombus 2200. In some embodiments, the expandable cylindricalportion 208 can unstack during the proximal retraction of the thrombusextraction device 202. In some embodiments, this unstacking can beaccomplished by proximally retracting the coring element shaft 140 withrespect to the tip shaft 200. In some embodiments, this can be achievedby merely retracting the coring element shaft 140 and allowing dragcaused by the thrombus entering the expandable cylindrical portion 208to prevent the tip shaft 200 to moving simultaneous with and/or to thesame degree as the coring element shaft 140. In some embodiments, thisunstacking can be achieved by maintaining the pinning of the tip shaft200 while retracting the coring element shaft with respect to the tipshaft 200.

The thrombus extraction device 202 can be unstacked until the entirethrombus extraction device 202 is unstacked or until a desired level ofunstacking is achieved. The thrombus extraction device 202 can then beretracted via the proximal retraction of the thrombus extractioncatheter 104, the outer shaft 138, and/or the coring element shaft 140.In some embodiments, the thrombus extraction device 202 can be retracteduntil all or a portion of the thrombus extraction device 202 is withinthe funnel catheter 3500, and specifically within the funnel 1708. Insome embodiments, for example, the thrombus extraction device can beretracted until the self-expanding coring element 206 is within thefunnel 1708 and/or until the mouth 414 is within the funnel. In someembodiments, the containment of the mouth 414 within the self-expandingfunnel 1708 can be fluoroscopically verified. In some embodiments, themouth 414 can be determined as wholly contained within theself-expanding funnel 1708 via fluoroscopic monitoring based on thealignment/relative positioning of the distal end 212 of the intermediateshaft 140 comprising a radiopaque marker 2450 and/or the radiopaquemarker 222 with respect to the distal end 110 comprising a radiopaquemarker 2452 of the elongate member 106 of the introducer sheath 102.

After the mouth 414 of the thrombus extraction device 202 is within thefunnel 1708, the position of the thrombus extraction device 202 can bemaintained such that the mouth 414 of the thrombus extraction device 202remains in the funnel 1708 while the thrombus extraction device 202 andthe funnel catheter 3500 are simultaneously withdrawn from the patientthrough the inserter sheath 102. In some embodiments, thrombus can becaptured within the self-expanding funnel 1708, and the thrombus can beaspirated out of the patient via the funnel catheter 3500, andspecifically via the lumen of the funnel catheter 3500, the connectingtube 3512, and the aspiration port 3510.

Other variations are within the spirit of the present invention. Thus,while the invention is susceptible to various modifications andalternative constructions, certain illustrated embodiments thereof areshown in the drawings and have been described above in detail. It shouldbe understood, however, that there is no intention to limit theinvention to the specific form or forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructions,and equivalents falling within the spirit and scope of the invention, asdefined in the appended claims.

In the previous description, various embodiments of the presentinvention are described. For purposes of explanation, specificconfigurations and details are set forth in order to provide a thoroughunderstanding of the embodiments. However, it will also be apparent toone skilled in the art that the present invention may be practicedwithout the specific details. Furthermore, well-known features may beomitted or simplified in order not to obscure the embodiment beingdescribed.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. The term “connected” is to beconstrued as partly or wholly contained within, attached to, or joinedtogether, even if there is something intervening. Recitation of rangesof values herein are merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value isincorporated into the specification as if it were individually recitedherein. All methods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any and all examples, or exemplarylanguage (e.g., “such as”) provided herein, is intended merely to betterilluminate embodiments of the invention and does not pose a limitationon the scope of the invention unless otherwise claimed. No language inthe specification should be construed as indicating any non-claimedelement as essential to the practice of the invention.

Preferred embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention.Variations of those preferred embodiments may become apparent to thoseof ordinary skill in the art upon reading the foregoing description. Theinventors expect skilled artisans to employ such variations asappropriate, and the inventors intend for the invention to be practicedotherwise than as specifically described herein. Accordingly, thisinvention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

What is claimed is:
 1. A method for removal of thrombus from a bloodvessel in a body of a patient, the method comprising; providing athrombus extraction device comprising a proximal self-expanding memberformed of a fenestrated structure, and a substantially cylindricalportion formed of a net-like filament mesh structure having a proximalend coupled to a distal end of the fenestrated structure; advancing acatheter constraining the thrombus extraction device through a vascularthrombus, deploying the thrombus extraction device by stacking a portionof the net-like filament mesh structure outside of the catheter bydistally advancing the self-expanding member until the self-expandingmember is beyond a distal end of the catheter; retracting theself-expanding member relative to the distal end of the net-likefilament mesh structure to unstack the portion of the net-like filamentmesh structure and to separate a portion of the thrombus from the vesselwall and to capture the portion of the thrombus within the net-likefilament mesh structure; and withdrawing the thrombus extraction devicefrom the body to remove thrombus from the patient.
 2. The method ofclaim 1, wherein advancing the catheter through the vascular thrombuscomprises inserting the catheter into the blood vessel until aradiopaque distal tip of the catheter is past the thrombus portion. 3.The method of claim 1, wherein stacking the portion of the net-likefilament mesh structure comprises: fixing a position of the distal endof the net-like filament mesh structure; and distally advancing theself-expanding member relative to the distal end of the net-likefilament mesh structure.
 4. The method of claim 3, wherein the positionof the distal end of the net-like filament mesh structure is fixedproximal relative to a valve in the body of the patient.
 5. The methodof claim 4, wherein the valve is located in the blood vessel containingthe thrombus.
 6. The method of claim 4, wherein the position of thedistal end of the net-like filament mesh structure is fixed in a secondblood vessel, wherein the second blood vessel is connected to the bloodvessel containing the thrombus.
 7. The method of claim 3, whereinstacking the portion of the net-like filament mesh structure compriseschanging a braid angle of portion of the net-like filament meshstructure.
 8. The method of claim 7, wherein the braid angle of theportion of the net-like filament mesh structure is greater than 45° whenstacked.
 9. The method of claim 1, wherein a diameter of the portion ofthe net-like filament mesh structure is greater than a diameter of thefenestrated structure.
 10. The method of claim 1, wherein the catheteris inserted into the blood vessel through a popliteal access site andthe catheter is distally advanced from the popliteal access site. 11.The method of claim 1, wherein the net-like filament mesh structure isinterwoven on the fenestrated structure.
 12. The method of claim 1,further comprising moving the fenestrated structure to full expansion.13. The method of claim 12, wherein moving the fenestrated structure tofull expansion comprises retracting a stop shaft relative to thefenestrated structure.
 14. The method of claim 13, wherein the stopshaft is retracted relative to the fenestrated structure via movement ofa plunger from a first position to a second position.
 15. The method ofclaim 13, wherein the stop shaft is retracted relative to thefenestrated structure via movement of a shuttle from a first position toa second position, wherein the shuttle is moved from a first position toa second position via a force applied to the shuttle by a spring. 16.The method of claim 1, wherein advancing the catheter through thevascular thrombus comprises inserting the catheter into the blood vesselthrough a funnel catheter comprising: an elongate sheath; and aself-expanding funnel coupled to a distal end of the elongate sheath.17. The method of claim 16, withdrawing the thrombus extraction devicefrom the body to remove thrombus from the patient comprises retractingthe thrombus extraction device until at least a portion of theself-expanding member is contained within the self-expanding funnel. 18.The method of claim 16, wherein the at least a portion of theself-expanding member contained within the self-expanding funnelcomprises an opening of the self-expanding member.
 19. The method ofclaim 18, further comprising simultaneously proximally retracting thethrombus extraction device and the funnel catheter from the patient. 20.The method of claim 19, wherein the opening of the thrombus extractiondevice is maintained within the self-expanding funnel during thesimultaneous proximal retraction of the thrombus extraction device andthe funnel catheter from the patient.
 21. A method for removal ofthrombus from a blood vessel in a body of a patient, the methodcomprising; advancing a catheter constraining a thrombus extractiondevice through a vascular thrombus, the thrombus extraction devicecomprising a proximal self-expanding member formed of a fenestratedstructure, and a substantially cylindrical portion formed of a net-likefilament mesh structure having a proximal end coupled to a distal end ofthe fenestrated structure, deploying the thrombus extraction device bydistally advancing the self-expanding member with respect to thecatheter until the self-expanding member is beyond a distal end of thecatheter, wherein deploying the thrombus extraction device comprisesstacking a portion of the net-like filament mesh structure, whereinstacking a portion of the net-like filament mesh structure comprises:fixing a position of the distal end of the net-like filament meshstructure; and distally advancing the self-expanding member relative tothe distal end of the net-like filament mesh structure; retracting theself-expanding member relative to a distal end of the net-like filamentmesh structure to increase a distal length of the net-like filament meshstructure and to separate a portion of the thrombus from the vessel walland to capture the portion of the thrombus within the net-like filamentmesh structure; and withdrawing the thrombus extraction device from thebody to remove thrombus from the patient.
 22. The method of claim 21,wherein advancing the catheter through the vascular thrombus comprisesinserting the catheter into the blood vessel until a radiopaque distaltip of the catheter is past the thrombus portion.
 23. The method ofclaim 21, wherein stacking a portion of the net-like filament meshstructure comprises changing a braid angle of portion of the net-likefilament mesh structure.
 24. The method of claim 23, wherein the braidangle of the portion of the net-like filament mesh structure is greaterthan 45° when stacked.
 25. The method of claim 21, wherein a diameter ofthe portion of the net-like filament mesh structure is greater than adiameter of the fenestrated structure.
 26. The method of claim 21,wherein the catheter is inserted into the blood vessel through apopliteal access site and the catheter is distally advanced from thepopliteal access site.
 27. The method of claim 21, wherein the net-likefilament mesh structure is interwoven on the fenestrated structure. 28.The method of claim 21, further comprising moving the fenestratedstructure to full expansion.
 29. A method for removal of thrombus from ablood vessel in a body of a patient, the method comprising; advancing acatheter constraining a thrombus extraction device through a vascularthrombus, the thrombus extraction device comprising a proximalself-expanding member formed of a fenestrated structure, and asubstantially cylindrical portion formed of a net-like filament meshstructure having a proximal end coupled to a distal end of thefenestrated structure, wherein advancing the catheter through thevascular thrombus comprises inserting the catheter into the blood vesselthrough a funnel catheter comprising: an elongate sheath; and aself-expanding funnel coupled to a distal end of the elongate sheath,deploying the thrombus extraction device by distally advancing theself-expanding member with respect to the catheter until theself-expanding member is beyond a distal end of the catheter; retractingthe self-expanding member relative to a distal end of the net-likefilament mesh structure to increase a distal length of the net-likefilament mesh structure and to separate a portion of the thrombus fromthe vessel wall and to capture the portion of the thrombus within thenet-like filament mesh structure; and withdrawing the thrombusextraction device from the body to remove thrombus from the patient.